Needle and suture swaging and pull-testing method

ABSTRACT

An method and apparatus for automatically forming a plurality of needle-suture assemblies out of a plurality of unsorted needles and an indefinite length strand of suture material, and, automatically positioning them within a package tray, comprises a first machine located at a first location for sorting a plurality of randomly oriented needles and orienting each needle for automatic handling at a first predetermined location, a second machine located at a second predetermined location for automatically drawing and cutting an indefinite length strand of suture material and automatically inserting a free end thereof into a suture receiving opening of the needle, and swaging the needle about the sutures to form a needle suture assembly, and a first indexing device for sequentially .receiving individual oriented needles at the first location and transporting each of the needles from the first location to the second location to form the needle-suture assemblies. A second indexing device is provided for registering an empty package tray at a third location for sequentially receiving one or more of the needle-suture assemblies from the first indexing device. A control system computer enables the first indexing device to sequentially transport the needle-suture assemblies from the second location to the third location, and enables the sequential insertion of the needle-suture assemblies to the package tray while registered at the third location.

This is a divisional of copending application Ser. No. 08/181,607, filedon Jan. 13, 1994.

1. Field of the Invention

The present invention relates generally to machines for automaticallyproducing armed surgical needles, i.e., needles having a suture strandof predetermined length attached at one end thereof, and automaticallypackaging the same, and more specifically, to a control system forcontrolling the processes involved in the automatic production, testing,and packaging of armed surgical needles.

2. Description of the Prior Art

Presently, armed surgical needles used by surgeons and medical personnelare manufactured utilizing manual and semi-automated procedures such asthose described in U.S. Pat. Nos. 3,611,551, 3,980,177, and 4,922,904.For instance, as described in U.S. Pat. No. 3,611,551, manualintervention is required by an operator to accurately position a suturetip within a suture receiving opening of a surgical needle to accomplishswaging thereof. This process is costly in terms of man-hour labor andefficiency because of the manual manipulations involved.

Indefinite length of suture material may be supplied wound on a bobbin,or, a king or driven spool before being cut and positioned within theswaging end of a surgical needle. In U.S. Pat. No. 3,980,177 the suturematerial is fed from a spool and taken up on a rotating tension rackwhere uniform length strands are subsequently cut. Thus, the length ofthe suture is determined by the size of the rack and manual interventionis required to prepare the rack for the cutting of the suture materialwound thereabout. Moreover, manual intervention is required to changethe rack each time a suture strand of different length is desired.

In U.S. Pat. No. 4,922,904, the suture material is supplied wound on abobbin and is fed through various guide means prior to insertion withinthe suture receiving end of the surgical needle. In one embodiment showntherein, an elaborate television monitoring means is required foraligning the drawn suture within the suture receiving opening of thesurgical needle prior to swaging thereof. In the same embodiment, arotary encoder device is used to determine the length of suture materialunwound from the bobbin prior to cutting. In an alternative embodiment,after swaging of the indefinite length of suture material to the needle,the needle-suture assembly is additionally fed a predetermined distanceprior to cutting to obtain a suture strand of predetermined length.Thus, to obtain uniform lengths of suture material every time requirescareful manipulations and precise controls, and the processes used toaccomplish these tasks are slow and inefficient.

Additionally, at the present time, the introduction of needles withattached sutures into suture packages or molded plastic trays is beingimplemented in a substantially manual manner. In that instance, theneedles are manually placed into the tray so as to be clampingly engagedby means of suitable needle-gripping structure, and thereafter theattached sutures are wound or positioned within the confines of thetray. Subsequently, a suitable cover is superimposed upon and fastenedto the filled tray, and the resultant suture package conveyed to asuitable arrangement for possible sterilizing or further overwrapping.

The foregoing essentially manual and relatively basic process forwinding the sutures into the tray, and especially the locating thereofinto the peripheral channel of the tray during manipulation of the tray,is quite time-consuming, and in conjunction with the manual applicationof the cover into the tray in a basically individual or piece-by-piecemode, represents a serious hindrance to a high volume mass producedmanufacturing output, and adversely affects the economics in attemptingto provide such large quantities of suture packages containing multiplesurgical needles and attached sutures.

In view of the limitations of the devices described in theaforementioned patents, it would be desirable to provide a needlethreading and swaging machine that is fully automated and which canautomatically prepare surgical needles having uniform lengths of suturematerial attached thereto.

Furthermore, it would be desirable to provide a packaging machinefacilitating the automated high-speed packaging of surgical needleshaving sutures attached thereto.

Furthermore, it would be highly desirable to provide an automatichigh-speed needle threading and swaging system and automatic high-speedpackaging system that is computer controlled and that can provideautomatic adjustments to the swage tooling dies when different sizesutures are swaged to correspondingly sized surgical needles.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide acontrol system for a high-speed, automatic needle-suture assembly andpackaging system.

It is another object of the instant invention to provide acost-effective automatic needle threading and swaging system andautomatic packaging system that virtually eliminates operator exposureto any repetitive manual operations.

It is still another object of the instant invention to provide anautomatic needle-suture assembly and packaging system that incorporatesa rotatable swage dial having a plurality of multi-axis grippers thatautomatically grip surgical needles for indexing to a plurality ofprocessing stations that include: a loading station for transferringindividual precisely oriented surgical needles from a conveyor to themulti-axis grippers; a swaging station that automatically draws anindefinite length strand of suture material, cuts the strand, insertsthe free end of the definite length strand within the suture receivingend of the needle, and swages the suture strand to the surgical needle;a pull-test station that automatically performs minimum and n-countdestructive pull-testing of the needle-suture combination; and finally,a needle-suture load to package station where armed, pull-tested needlesare transferred to the automatic packaging station for packagingthereof.

Yet another object of the present invention is to provide an automaticneedle-suture assembly and packaging system that incorporates arotatable suture winding and packaging dial for automatically packagingarmed surgical needles with a variety of processing stations thatinclude: a package load station for loading an empty package tray onto asupporting structure of the tool nest; a package detect station fordetecting the presence of an empty package tray; a needle-suture load topackage station where armed needles are transferred to the package fromthe rotary swage dial; a needle check station where the presence orabsence of the armed needles is checked; a winding station where thesutures that depend from each surgical needle are gathered to a bundleand wound around a peripheral channel located about the periphery of thepackage tray; a cover loading station where a cover is applied to thepackage; and finally, a package removal station where the completedpackage is removed from the machine, or rejected if the package isflawed.

Yet still another object of the present invention is to provide a needlethreading and swaging system that can provide continuous on-line tooladjustments without unnecessary interruptions and without manualintervention.

These and other objects of the present invention are attained with anautomated system for attaching suture material to a suture receivingopening formed in a surgical needle, and packaging the same, the systemcomprising a first means located at a first location for sorting aplurality of randomly oriented needles and orienting each needle forautomatic handling at a first predetermined location. A second meanslocated at a second location is provided for automatically drawing andcutting an indefinite length strand of suture material and automaticallyinserting a free end thereof into the suture receiving opening of saidneedle and swaging the needle about the sutures to form a needle sutureassembly. A first indexing means sequentially receives individualoriented needles at the first location and transports each of theneedles from the first location to the second location to form theneedle-suture assembly. A second indexing means is provided forregistering an empty package tray at a third location for sequentiallyreceiving one or more of the needle-suture assemblies from the firstindexing means. A control means enables the first indexing means tosequentially transport the one or more needle-suture assemblies from thesecond location to the third location, and enables the sequentialinsertion of one or more of the needle-suture assemblies to the packagetray while registered at the third location.

Further benefits and advantages of the invention will become apparentfrom a consideration of the following detailed description given withreference to the accompanying drawings, which specify and show preferredembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a conceptual top view of the needle threading and swagingmachine and automatic packaging machine that are operable under thecontrol system of the instant invention;

FIG. 2 is a detailed illustration of a typical surgical needle 9 havingan arcuate portion 8 and suture receiving end 7;

FIGS. 3(a)-3(h) are flow diagrams illustrating the sequential processestaking place at the rotary swage dial and operable under the controlsystem of the instant invention;

FIGS. 4(a)-4(n) are flow diagrams illustrating the sequential processestaking place at the suture winding and packaging dial and operable underthe control system of the instant invention;

FIG. 5 is a top view of the needle sorting station 100 of the automatedneedle threading and swaging system;

FIG. 6 illustrates the precision conveyor handing off surgical needle 9to the multi-axis gripper 155;

FIG. 7 is a top view of the rotary swage dial assembly 150 comprising aswage dial plate 110 having four multi-axis gripper stations 145a,b,c,dmounted thereon;

FIG. 8(a) is cross-sectional view of the four station swage dialassembly 150 showing multi-axis gripper 155 in a retracted position;

FIG. 8(b) is cross-sectional view of the four station swage dialassembly 150 showing multi-axis gripper 155 in an extended position;

FIG. 9(a) is detailed top view of the cam dial assembly 120 having camdial plate 125 with cam follower 165a in a retracted position within camtrack 60a;

FIG. 9(b) is cut away top view of the cam dial plate 125 showing camfollower 165a in an extended position within cam track 160a;

FIG. 10 is a cross-sectional view of the cam dial plate 125 mountedcoaxial with the swage dial plate 110 for cooperative rotationalmovement thereof, and showing cam followers 165a and 165c positionedwithin their respective cam tracks 160a and 160c;

FIG. 11(a) is front face view of the multi-axis gripper 155 showing asurgical needle 9 in a relaxed engagement thereby, and additionallyshowing pin 142 in a retracted position;

FIG. 11(b) is front face view of the multi-axis gripper 155 showing asurgical needle 9 in an engaged position therein;

FIG. 12 is an enlarged view of a gripper assembly having gripper arms265a,265b shown in their closed (suture gripping) and open positions;

FIG. 13 is a detailed view of the servo (suture drawing) tower includingthe automatic swaging station 200 with cutter assembly 280 and heaterassembly 290 mounted on tip and cut carrier 180, and the right gripper232 registering indefinite length suture strand tip 258 for insertionwithin end 7 of surgical needle 9 shown engaged by the multi-axisgripper 155;

FIG. 14 is a detailed view of the optional suture tensioning (dancer)assembly.

FIG. 15(a) is a detailed view of the gripper 232 shown inserting thesuture tip 258 within the confines of the suture receiving end of thesurgical needle;

FIGS. 15(b)-15(f) illustrate the multi-axis needle gripper 155 andswaging and suture alignment dies shown in various stages of the sutureinsertion and needle swaging sequence;

FIG. 16(a) is a top view of the swage assembly 390 of the instantinvention with the multi-axis gripper 155 indexed thereat;

FIG. 16(b) is a detailed view of the swage stop mechanism for swageassembly 390.

FIG. 17 is a detailed top view of the cutter assembly 280. FIG. 17 forcutting material in the instant invention;

FIG. 18 is a detailed top view of the cutter assembly 280 shown in afully retracted position;

FIG. 19 is a detailed top view of the cutter assembly 280 shown in afully extended (cutting) position;

FIG. 20 is an assembly drawing of the automatic pull-test station 300 ofthe instant invention;

FIG. 21(a) is a front view of the automatic pull-test station 300 of theinstant invention with the needle fence assembly 340 partially removed.

FIG. 21(b) is a detailed front view of the slide assembly means whileperforming a minimum pull-test.

FIG. 21(c) is a detailed front view of the slide assembly means whileperforming a destructive pull-test.

FIG. 22 is a top view of the load cell assembly 330 of the automaticpull-test assembly;

FIG. 23 is an enlarged view of an armed needle 9 supported by the suturereceiving blade 336b of the load cell 335 with the suture threadedbetween the suture receiving opening 334;

FIG. 24 is a detailed view of the needle stripper assembly 380 forremoving the needle 9 after a destructive pull-test or after minimumpull-test failure;

FIG. 25 illustrates a top plan view of the suture wind and packagingturret of the automatic packaging machine for needle-suture assemblies;

FIG. 26 illustrates, on an enlarged scale, a detailed side view of therotary disk showing one of the tool nests for mounting a needle andsuture-receiving tray;

FIG. 27 illustrates a front view of the tool nest of FIG. 26;

FIG. 28(a) illustrates a fragmentary top view of the rotary turret,showing an enlarged portion thereof incorporating one of thetray-mounting tool nests;

FIG. 28(b) illustrates an enlarged fragmentary detail of the encircledportion in FIG. 28(a);

FIG. 29 illustrates, generally diagrammatically a package detectorassembly operatively utilized in conjunction with the rotary disk asshown in FIG. 25;

FIG. 30 illustrates an elevational view of the detector assembly asviewed in the direction of line 30--30 in FIG. 29;

FIG. 31 is a perspective view of the discharge station 600 where rotarysuture winding and packaging turret 514 indexes empty package 420 forreceiving an armed needle from the multi-axis gripper 155;

FIG. 32(a) illustrates, on an enlarged scale, the suture tray of FIG. 46with the device for elevating the tray to enable a plurality of needlesto be parked therein;

FIG. 32(b) illustrates a side view of the suture tray;

FIG. 32(c) illustrates an enlarged fragmentary view of the encircledportion of FIG. 32b;

FIGS. 33(a) through 33(c) illustrate tilting mechanisms which areoperatively associated with the tray elevating device of FIG. 32.

FIG. 34 illustrates a side view of the needle detector arrangement;

FIGS. 35(a) through 35(c) schematically illustrate, respectively,various stages in the operation of the suture winding arrangement;

FIG. 36 is an enlarged fragmentary view of the encircled portion of FIG.35(c);

FIG. 37 illustrates a side view of a suture retaining unit in operativecooperation with the winding arrangement of FIGS. 35(a) through 35(c);

FIG. 38 illustrates a top view of the suture retaining unit of FIG. 37;

FIGS. 39(a) through 39(c) illustrate, respectively, operative drivestructure for the suture winding arrangement, shown on an enlargedscale, taken along line 39--39 in FIG. 37;

FIG. 40 illustrates a front elevational view of the cover applyingdevice in two operative conditions thereof;

FIG. 41 illustrates a side elevational view of the cover-applying deviceof FIG. 40;

FIG. 42 illustrates a top plan view showing the cover-applying deviceand the cover-pressing die of FIG. 40;

FIG. 43 illustrates an elevational side view of a suture packageunloading arrangement in two operative conditions thereof;

FIG. 44 illustrates a view in the direction of the arrow 44--44 in FIG.43;

FIG. 45 illustrates, on an enlarged scale a fragmentary view of theencircled portion in FIG. 43;

FIG. 46 illustrates a front view of a tray having needles and suturesarranged therein;

FIG. 47 illustrates a perspective view of a completed suture package;and

FIG. 48 illustrates, on an enlarged scale, a sectional view of one ofthe latching elements between the tray and an associated tray cover.

FIGS. 49(a)-49(g) illustrate the initialization or re-initializationroutines utilized in the present invention; and,

FIGS. 50(a)-50(e) illustrate the pneumatic control circuitry of theneedle-suture assembly and suture wind and packaging systems ascontrolled by the control system of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Generally, as shown in the conceptual plan view of the needle threadingand swaging system and needle-suture packaging system of FIG. 1,parallel operations take place simultaneously at four (4) differentworkstations positioned about a rotary swage dial 150 to enable theassembly, swaging and discharge of approximately sixty (60) surgicalneedles per minute with sutures attached thereto. Additionally, paralleloperations take place simultaneously at eight (8) different workstationspositioned about the larger suture winding and packaging dial 500 wherethe armed surgical needles are automatically parked into a reduced sizeorganizer package of unique construction. FIG. 2 illustrates a typicalsurgical needle 9 having a suture receiving opening or end 7 for swaginga suture strand thereto, and an arcuate blade portion 8.

The automatic needle threading and swaging apparatus shown in FIG. 1includes four workstations located about the periphery of the rotaryswage dial 150 that are successively utilized to form needle-sutureassemblies. These workstations include: a needle sorting station 100that sorts, singulates, and conveys precisely oriented surgical needlesto a plurality of retractable (multi-axis) grippers mounted on therotary swage dial 150. The rotary swage dial 150 successively rotatescounter-clockwise as shown by arrow "A" in FIG. 1, to index each needleto the automatic swaging station 200 where the suture material insertedinto the needle, cut, and automatically swaged thereto. Next, the rotaryswage dial 150 rotates further to index the armed needle to theautomatic pull-test station 300 where each armed needle is pull-testedto ensure that minimum and/or destructive pull-test requirements aremet. Then, the rotary swage dial 150 indexes the pull-tested armedneedle to a discharge station 600 where the armed surgical needles arehanded off to a package tray of unique construction at the suturewinding and packaging turret 500 for automatic packaging thereof.Hereinafter, the discharge station 600 will be referred to as theneedle-suture load to package station.

Generally, the automatic packaging apparatus shown in FIG. 1, includeseight (8) workstations located about the periphery of the rotary suturewind and packaging dial 500 that are successively utilized to form thecompleted package of surgical needles. These stations include: a packageload station 400 for successively feeding an empty package onto asupport plate of a tool nest mounted on the packaging dial; an optionalpackage detect station 450 for checking the presence of the loaded emptypackage; the needle/suture to package load station 600; an optionalneedle check station 475 for detecting missing needles; a suture windingstation 550 where the trailing sutures of the armed needles are gatheredand wound into the package; an optional manual inspection station 625; apaper insert station 650 where a paper cover is applied to the package;and, a package removal station 700 where the completed package isremoved from the machine for further processing, or, if the package hasbeen found defective during inspection, is scrapped.

All of the processes performed at the apparatuses mentioned above anddescribed in detail hereinbelow are controlled by the control system ofthe instant invention and implemented by software program(s) resident inthe control system computer 99 as shown in FIG. 1. Alternatively, thecontrol system may be implemented in a plurality of programmable logiccontrollers or other such suitable control devices (not shown).

FIGS. 3(a)-3(h) illustrate the automatic needle threading and swagingprocesses 10 operable under the control of the control system of theinstant invention. To the extent possible, each process performed ateach workstation, as illustrated in FIG. 3(a), will be described belowin the sequential manner as illustrated. When the needle threading andswaging system is in steady state operation, the sequence of operativesteps as shown in FIG. 3(a) is continually repeated to produce armedsurgical needles at a rate of approximately 60/min.

To begin, the control system 99 initiates power up of the variousdevices utilized in the automatic needle threading and swaging systemand the automatic suture winding and packaging system as indicated atstep 12 in FIG. 3(a). At this point, an operator may be prompted to setup the dies for the swaging assembly that correspond to the size of thebatch of needles to be processed. Additionally, any other necessaryadjustments and setups may be performed for each assembly, for e.g., toinitialize the Adept® robot assembly at the needle sorting station 100.Also as part of the power up display, an operator may be prompted tochoose between operating the system in the normal, fully automatic mode,or, in a single step mode, perhaps for diagnostic trouble-shootingpurposes. This power up routine may be part of a greater initialization(or reinitialization) routine discussed below with respect to FIGS.49(a) through 49(g).

Needle Sorting Station

The needle sorting station 100 is activated to sort, singulate, andconvey individual and precisely oriented surgical needles to each offour multi-axis grippers mounted on the rotary swage dial assemblyindexed at station 100.

At the needle sorting station 100 illustrated in FIG. 5, a batch ofunoriented needles of uniform size are first loaded into vibratory bowls101a,b, automatically sorted and linearly fed by singulating devices102a,b to each of two translucent indexing conveyors 105a,b, evaluatedwith respect to orientation and position by a vision tracking system(not shown), picked up by either of two robotic apparatuses 106a,b,transferred to individual engagement devices (boats) 108 located on aprecision conveyor 107 by each robot apparatus, and finally conveyed tothe rotary swage dial assembly where the needles are transferred to amulti-axis gripper at step 15a in FIG. 3(a) for subsequent transfer tothe swaging station 200. A detailed explanation of the needle sortingapparatus 100 is explained in further detail in copending U.S. patentapplication Ser. No. 08/181,600 (attorney docket 8920), and a detailedexplanation of the robotic control system utilized therein is describedin copending U.S. patent application Ser. No. 08/181,624 (attorneydocket 8921) both of which are assigned to the same assignee as thepresent invention, and incorporated by reference herein.

Generally, to accomplish the transfer of the needle to the multi-axisgripper at step 15a in FIG. 3(a), the multi-axis gripper 155 isregistered at station 100 so that the gripper pin assembly 152 thereofis confronting the needle precision conveyor boat 108 as shown in FIG.6. As indicated at step 15a and as described in further detail belowwith respect to FIG. 3(b), the multi-axis gripper pin assembly and pins146 and 148 thereof are able to penetrate a plane formed by thecurvature of needle 9. Then, the control system 99 initiates the commandfor a solenoid or plunger 143 to depress plunger 149 to retract anengagement pin of the pin assembly 152 and enable the needle to becomedeposited between pins 146 and 148 of the multi-axis gripper 155.Simultaneously, the control system 99 initiates the command for asolenoid of similar device to open engagement jaws 111,112 of theprecision conveyor boat 108 to release the needle 9 and effectuate thetransfer of the needle to the pin assembly 152 of the multi-axisgripper. A front view of the multi-axis gripper 155 retaining the needle9 after transfer from the precision conveyor boat 108 is illustrated inFIG. 11(b).

The description hereinbelow of the sequence of steps shown in FIG. 3(a)assumes steady state operation, i.e., that surgical needles have beentransferred from the needle sorting apparatus at workstation 100 ontoeach of the four multi-axis grippers mounted on the swage dial 150 thathave been successively indexed to station 100 at step 39 to receive theneedle from the precision conveyor at step 15a. In the preferredembodiment, the control system 99 initiates a needle transfer to themulti-axis gripper once every second to feed the swaging apparatus.Immediately prior to indexing a multi-axis gripper to workstation 100 atstep 39, the precision conveyor 107 has been indexed at step 33 and isdwelled for the next hand-off the needle to the multi-axis gripper.Immediately after indexing the precision conveyor at step 33, thecontrol system 99 sets a SAFE TO PLACE flag at step 33a indicating thatit is safe for one of the robot apparatuses 106a,b to place a needle onanother boat 108 located upstream of the swage dial 150.

Rotary Swage Dial/Multi-axis Gripper

Step 14 in FIG. 3(a), involves actuating a cam mechanism to enable eachmulti-axis gripper, indexed at each respective workstation 200, 300, 600to extend out from the rotary swage dial 150 and place each preciselyoriented surgical needle 9 that is gripped thereby, within eachrespective workstation for processing thereat. This is explained indetail as follows:

As illustrated in FIGS. 1 and 7, the rotatable swage dial assembly 150includes four multi-axis grippers each retaining a needle for processingto occur simultaneously at workstations 100, 200, 300, and 600. In thedetailed illustration of FIG. 7, the swage dial assembly 150 includes aswage plate 110 having four multi-axis gripper stations 145a, 145b,145c, 145d spaced equally thereon. The swage plate 110 is rotatablymounted at a central hub 109 and is rotated by suitable drive motors(not shown) operable under the control of the control system computer99.

As shown in FIG. 7, multi-axis gripper station 145a includesreciprocating carriage 151a, while station 145b includes reciprocatingcarriage 151b, station 145c includes reciprocating carriage 151c, andstation 145d includes reciprocating carriage 151d. Mounted to eachreciprocating carriage 151a,b,c,d for reciprocal movement therewith, aremulti-axis grippers, one of which 155 is shown connected to grippercarriage 151c in FIG. 7. Each gripper carriage 151a,b,c,d and multi-axisgripper 155 thereof is movable from a retracted position to an extendedposition. During steady state operation of the system, when each gripper155 is in its retracted position shown in FIG. 8(a), each needle 9carried thereby may be indexed to the next successive workstation as theswage plate 110 rotates; when a gripper 155 is in its extended positionas shown in FIG. 8(b), a needle 9 is in one of the processing stations,for e.g., the automatic swaging station 200, or, the automatic pull-teststation 300 for processing thereof.

The mechanism for extending each multi-axis gripper 155 is shown inFIGS. 8(a) and 8(b), 9(a)-9(b) and FIG. 10. In FIG. 8(a), a cam follower165a(b,c,d) is mounted to a cam slide 164 at one end of eachreciprocating carriage 151a(b,c,d), and the multi-axis gripper 155 isconnected to the cam slide 164 at the other end. Cam slide 164 isslidable within stationary guides 166,167 and is adapted for reciprocalmovement when the cam follower 165a(b,c,d) is actuated by a cam dialassembly. In the preferred embodiment shown in FIG. 9(a), cam follower165 is a roller that fits within cam tracks of a rotatable cam dialassembly 120. Cam dial assembly 120 is shown in FIG. 9(a) as comprisinga cam dial plate 125 having four cam tracks 160a,b,c, and 160d whichcorrespond to respective multi-axis gripper stations 145a,b,c, and 145d.Each cam follower 165 is positioned within each respective cam track ateach station for movement therein. For instance, in the cutaway sideview shown in FIG. 10, cam follower 165a is positioned within cam track160a and cam follower 165c is positioned within cam track 160c. Also inFIG. 10, the cam dial plate 125 is positioned within the swage dialassembly 150 and mounted coaxial therewith. The cam dial plate 125 isrotatable about a central shaft 199 and operated by a separate rotaryindexing transmission (not shown) under the control of the controlsystem 99, so that it may rotate separately from the swage dial plate110. FIG. 9(a) shows cam follower 165a in a first retracted positionwithin the cam track 160a. When in this position, reciprocating carriage151a and consequently multi-axis gripper 155 are in their retractedposition as shown in FIG. 8(a) discussed above. To extend eachmulti-axis gripper 155 in place at its respective station as indicatedat step 14 in FIG. 3(a), the cam dial plate 125 is rotated in theclockwise direction indicated by the arrow in FIG. 9(a), forapproximately 45-55 degrees with respect to the swage plate 110, forcingcam follower 165a in its cam track 160a to move toward the periphery ofthe dial as shown in FIG. 9(b). Consequently, the cam slide 164,reciprocating carriage 151a, and the multi-axis gripper 155 move to theextended position as shown in FIG. 8(b) and discussed above.

It should be understood that when cam dial plate 125 rotates clockwisewith respect to swage plate 110, each multi-axis gripper 155 is extendedwithin its respective cam track. Thus, during steady state operation,the system is designed so that all processes performed at eachworkstation occur simultaneously and for approximately the same durationof time when the multi-axis grippers are in their extended positions,for e.g., for needle pickup from the sorting station 100 (step 15a),needle swaging (step 23), for needle pull-testing (steps 19a,b), and forneedle-suture hand-off to the suture wind and packaging dial (step 25).

After each multi-axis gripper has been extended at respective stations200,300, and 600, the control system 99 initiates an extend multi-axisgripper release needle process for releasing each needle from the gripof the multi-axis grippers as indicated in the EXTEND MAG RELEASE NEEDLEsteps 15b,c,d in FIG. 3(a). The releasing of the needle 9 from grip ofthe multi-axis grippers at each workstation is desirable for performingthe processes at each station as discussed generally above with respectto step 15a. In the frontal view of the multi-axis gripper 155 shown inFIG. 11(b), pins 142, 146, and 148 of the multi-axis gripper 155 extendperpendicularly from the gripper pin assembly 152 of the gripper toengage the arcuate portion 8 of needle 9. The three pin needleengagement configuration shown in FIG. 11(b) ensures that the needle 9will not be displaced when the swage dial 150 is rotating, or, when themulti-axis gripper 155 is being retracted or extended. In the preferredembodiment, pin 142 is spring loaded and is retractable within guide 147to a non-engaging or relaxed position when a plunger 149 is depressed asshown in FIG. 11(a).

The control process 21 for relaxing each needle retained by eachmulti-axis gripper at each respective workstation is illustrated in FIG.3(b). First, the control system performs a check at step 22a to verifythat the rotary swage dial 150 is not in motion, i.e., that it hasstopped rotating upon reaching its indexed position. If the swage dialhas arrived at its indexed position, a cam solenoid 143 is actuated todepress the plunger 149 of the multi-axis gripper as shown in FIG.11(a). If the swage dial has not been indexed, the system will waituntil it is indexed before extending the cam (step 22b). While the camsolenoid is extending, a suitable proximity sensor (not shown) sensesits motion at step 26a and will inform the control system accordingly.The system performs a check at step 26b to determine whether a time-outflag has been generated by the control system indicating a time-outerror. If a time-out flag had not been generated, then the cam 143 hasbeen fully extended (step 26a) and that the needle has been relaxed fromthe grip of the multi-axis gripper. If the time-out flag is generated bythe control system indicating an error, the process will be terminatedand prompted for re-initialization at step 959.

At the same time the cam solenoid 143 is extended to relax the needlefor processing as indicated at steps 15b, 15c, and 15d in FIG. 3(a), theindefinite length of suture strand is drawn up a servo tower atworkstation 200 as indicated at step 16 in FIG. 3(a). The drawing of theindefinite length of suture strand is described in detail below and infurther detail in copending patent application Ser. No. 08/181,599(attorney docket No. 8937) assigned to the same assignee of the presentinvention and incorporated by reference herein.

Needle Threading and Swaging Station

As previously mentioned, the automatic swaging station 200 is where thesuture of indefinite length is drawn, cut, and inserted within thesuture receiving end of a surgical needle for swaging thereof.

The step 16 of drawing the indefinite length of suture material isaccomplished at a drawing tower 220 shown in FIG. 13. The drawing tower220 comprises left side rail 222 and right side rail 224 both mounted onsuitable mounting block 225 and defining a drawing bed for drawing anindefinite length of suture material along a drawing axis therebetween.Located parallel to the left and right side rails 222,224 and suitablyconnected thereto are respective left guide rod 226 and right guide rod228. The lead gripper means or right gripper 232 reciprocates up anddown along right guide rod 228 while the bottom gripper means or leftgripper 230 reciprocates up and down the left guide rod 226. Each of thegrippers 230,232 grip the suture material that is fed from a spoolthrough pulley 235 located at the bottom of the drawing tower 220, andcarries the material to the upper end of the tower. The right gripper232 is mounted on right gripper carrier 233 for vertical movement alongright guide rod 228, and the left gripper 230 is mounted on left grippercarrier 231 for vertical movement along left guide rod 226 as shown inFIG. 13.

FIG. 12 illustrates a gripper 232 (and 230) having a gripper arm drive261 that is pneumatically operated to drive pair of retractable gripperarms 265a, 265b toward each other to a suture gripping position, or,away from each other to an open position. Each retractable gripper armis provided with a non-metallic pad 266a, 266b for gripping the suturematerial 255 at a free end thereof when actuated to the grippingposition. To release the grip of the suture, gripper arms 65a,265b areretracted approximately 180 degrees apart in the direction indicated bythe arrows of FIG. 18 to the open position. When in the open positionthe gripper arms 265a', 265b' do not interfere with the motion of theother vertically moving gripper as it reciprocates along the respectiveleft or right rod, nor will it interfere with the retractable cutterassembly 280 that cuts the strand to a predetermined length. Theretractable nature of the grippers and of the cutting assembly enablessingle drawing axis operation.

The pneumatic schematic diagram of FIG. 50(a) illustrates supply line701 that supplies pressurized air through suitable filter 702, throughpressure monitoring device 703a and through switching devices 707a and707b, to provide the pressurized air for controlling the gripper armdrive 261 of each respective gripper 230 and 232. Specifically, thepressurized air supply line 701 is split into the pressure line 701a forsupplying air pressure to the top and bottom grippers 232,230,respectively, as shown in FIG. 50(a). Control signal lines 704a,binterface with the control system 99 to control the timing andpositioning of each switching device 707a,b. Thus, the pneumatic openingand closing of the gripper arms 265a,b of each retractable gripper230,232 are controlled by the control system 99.

As mentioned above, each gripper carrier and gripper thereof is designedto advance vertically along the respective left and right rods. As shownin FIG. 13, the right gripper 232 and gripper carrier 233 is driven byright servo motor 238 which is mounted to the right side rail 224 byright motor mounting bracket 239. Similarly, the left gripper 230 andgripper carrier 231 is driven by left servo motor 236 which is mountedto the left side rail 222 by left motor mounting bracket 237. In thepreferred embodiment, both left and right servo motors are interfacedwith and controlled by the control system computer 99. As shown in FIG.13, right servo motor 238 drives timing belt 243 which consequentlyenables vertical positioning of right gripper carrier 233 along rightrod 228, while the left servo motor 236 drives timing belt 241 whichconsequently enables vertical positioning of left gripper carrier 231along left rod 226. As FIG. 12 illustrates, timing belt 243 is clampedto its respective gripper carrier 233 by a timing belt clamp 268 locatedon the back of the gripper carrier. A similar timing belt clamp (notshown) is provided on gripper carrier 231 for clamping timing belt 241to enable vertical movement of gripper 230.

FIG. 13 also shows the tip and cut carrier 180 positioned along shafts204 and 205 which are located parallel to respective left and right rods226,228. Tip and cut carrier 180 provides the support for tippingassembly 290 that applies heat to a specific location of the suturematerial, and also provides support for the cutter assembly 280 thatcuts the suture material. Therefor, its vertical positioning is dictatedby the length of suture strands desired to be cut in any given batch.The vertical positioning of the tip and cut carrier 180 is accomplishedby cranking handwheel 208 shown in FIG. 13. Alternatively, a computercontrolled servo motor may vertically register the tip and cut carrier180 prior to cutting and heat tipping the suture material.

Both the stroke of the grippers 230,232 and the positioning of the tipand cut carrier 180 along drawing tower 220 dictates the length of thematerial that will be cut. For instance, as shown in FIG. 13, proximitysensors 273,274, and 275 are positioned vertically at different heightsalong the drawing tower 220 to enable predetermination of the length ofsuture material to be cut. Specifically, the locations of the proximitysensors 273,274, and 275 sense the positioning of the tip and cutassembly 180 as controlled by handcrank 208 in order to notify thecontrol system 99 to change the reciprocating travel of grippers230,232. Also as shown in FIG. 13, proximity sensor 270 is mounted at aposition along the right side rail 224 to verify that right gripper 232has reached a desired position at the upper end of the tower 220 andnotify the control system 99 accordingly. Likewise, a proximity sensor(not shown) is mounted at the desired height along the left side rail222 to verify that left gripper 230 has reached its desired position atthe upper end of the drawing tower 220.

When loading the indefinite length suture material, the suture material255 is first manually threaded through eyelet 256 and through optionalknot detector 257 which senses any sudden change in the thickness of thesuture material. Detection of a knot in suture material 255 duringsteady state operation will inform the control system 99 to enable thepull-test station to discard that strand of material, in the mannerdiscussed below, as indicated at steps 19a,b of FIG. 3(a). Additionally,the suture material may be threaded within a tensioning (or dancer)assembly 259 which comprises a plurality of vertically spaced apartcones 223 each of which may be positioned laterally to increase ordecrease the tension of the suture strand 255 as shown generally in FIG.14.

The suture material 255 is then advanced over pulleys 235a and 235blocated at the bottom of the drawing tower 220, and around pulley 212which is mounted on the lower portion of tip and cut carrier 180 that isillustrated near the center of the tower as shown in FIG. 13. Note thatthe lower threading pulley 235b, guide pulley 212, left gripper 230 andright gripper 232 are vertically aligned so that the cutter assembly 280will always cut horizontally across the strand of material.

The control process 30 for drawing of the indefinite length suturematerial up the servo tower at the swaging station, is illustrated inFIG. 3(c). At step 32, a check is made to ensure that the left and rightservomotors are operational. Additionally, a check is provided to ensurethat the left and right grippers and their corresponding gripper armdrives are operational and able to grip the suture strand. Next, asindicated in FIG. 3(c) at step 34, a check of the proximity sensorlocations is provided to determine the length of the suture strand to becut, i.e., to determine the reciprocating travel of the left (bottom)and right (top) grippers along the respective left and right guide rods.Immediately thereafter, as indicated in FIG. 3(c) at step 36, the rightservo motor 238 is enabled to drive the top (right) gripper verticallyalong right rod 228 to register the tip of the indefinite length suturestrand 255 for positioning within the suture receiving end 7 of aprecisely oriented surgical needle shown engaged by the multi-axisgripper 155 at the swaging assembly 390 located at the top of thedrawing tower 220 as shown in FIG. 13. To accomplish this, the leadgripper servomotor advances the lead gripper for a long stroke distance,which may range from 12 inches to 36 inches depending upon the length ofsaid suture strand desired. The long stroke moves right gripper 232 froma home position just above the tip and cut carrier 180 and below thecutter assembly 280, to the position slightly below swaging assembly 390as shown in FIG. 13.

Simultaneous with the positioning of the right gripper 232 during thelong stroke of step 36, the other servomotor, for e.g., servomotor 236,positions the bottom gripper, for e.g., left gripper 230, along left rod226 at the home position preferably above the tip and cut carrier 180and below the position of the cutter assembly 280 as shown in FIG. 13.It is understood that the lead gripper is gripping the material 255 atall times during the long stroke, while the bottom gripper is in itsopen position and not gripping (FIG. 12). The process of advancingsuture material 255 by alternating grippers at each cycle eliminates therecycle or return time for retaining the gripper to the originalposition. This makes faster machine speeds and hence, higher productionrates possible.

Finally, as indicated in FIG. 3(c) at step 38a, a continuous check isprovided to ensure that the lead gripper drawing the indefinite lengthsuture strand during the long stroke, has reached its verticaldestination along its respective guide rod as detected by proximitysensor 270 as shown in FIG. 13. If the lead gripper has not reached itsvertical position along the guide rod, the system will perform a checkat step 38b to determine whether a time-out flag has been generated bythe control system indicating a time-out error. If a time-out flag hasnot been generated, then the top or right gripper has reached itsvertical position, (step 38a) and the process continues. If the time-outflag is generated by the control system indicating a time-out error, theprocess will be terminated and prompted for reinitialization at step959.

Swaging Assembly

The swaging operation taking place at the swaging station will now bedescribed. FIGS. 15(a)-15(f) illustrate the multi-axis needle gripper155 and swaging and suture alignment dies shown in various stages of thesuture insertion and needle swaging sequence. This sequence, and theinteraction of the dies in relation to each other, the needle, and theinsertion of the suture, accomplish the insert and swage function withminimal parts and simple motions.

After conveying the needle to swaging assembly 390 shown in FIGS. 15(a)and 16(a), the multi-axis gripper 155 is radially extended (step 14)from the swage dial in the manner described above to position the suturereceiving end 7 of needle 9 between the funnel shaped die opening formedat the ends of two swage dies 361,369 as shown in FIG. 15(a) and thepartial perspective view of FIG. 15(b). As will be explained, swage die361 is fixed in position and swage die 369 is movable laterally towardthe fixed swage die 361, as indicated by the arrow, to accomplishswaging of the suture receiving end of a needle placed therebetween. Afunnel shaped die opening 392 having an exit diameter slightly largerthan the diameter of the suture receiving end 37 of the needle is formedwhen the two swage dies 361,363 are positioned adjacent each other asshown in FIGS. 15(e) through 15(f). In the preferred embodiment the endsof each of the swage dies 361,369 are provided with recesses so that themetal deformation that occurs as a result of the swaging of the needle9, does not result in metal flash or spurs at the suture receiving end 7of the needle. Note that different sets of swage dies may be provided,depending upon the size (diameters) of the needles and sutures to beswaged.

To precisely position the sutures receiving end 7 of needle 9 betweenthe swage die opening 392 formed at the ends of two swaging dies361,369, the movable swage die 369 is temporarily moved apart. In theillustration of the swaging assembly 390 shown in FIG. 16(a), swage die369 is moved apart from the fixed swage die 361 by actuating aircylinder 395 to provide a force upon cylinder rod 393 to enable swagedie operating lever 397 to pivot about screw 394 and pull moveable swagedie 368 a predetermined distance away from the fixed swage die 361. Inthe preferred embodiment, lever 397 is biased by spring 364 so that themovable swage die 369 will return toward the fixed swage die by thespring restoring force when the pressure provided by the air cylinder395 is terminated as controlled by the control system 99.

As shown in the pneumatic schematic of FIG. 50(a), supply line 701supplies pressurized air through suitable filter 702, through pressuremonitoring device 703a and through switching device 707c to provide thepressurized air for controlling the air cylinder 395 that provides theforce necessary for the swage dies to open for clamping of the needle 9at the swage die opening 392. The operation of the air cylinder 395 iscontrolled by control lines 704a,b which operate the switch 707c underthe timing and control of the control system 99.

FIG. 15(c) shows die 361 in its fixed position, and moveable die 369 inits spaced apart position prior to receiving the surgical needle 9presented by multi-axis gripper 155. Suture alignment die 362,containing suture guide funnel half 362b, is positioned under swage die361, and free to slide laterally within limits. Alignment die 362 has atang 362a that protrudes into cavity 361a formed within swage die 420.Compression spring 361c bears against the back wall of cavity 361a andtang 362a such that funnel die 362 slides forward until it isconstrained by cavity wall 361b. In this position, it is forward of thecenter axis defined by the suture receiving end of the needle, andserves as a shelf 362c that helps assure suture receiving end 7 ofneedle 9 is in position for swaging. In this stage of the cycle, theparts are not positioned for suture insertion, and suture clamp 265agripping suture 255 and stiffened end 258, are in dwell. Suturealignment die 368, containing funnel half 363, is fastened to swage die369 by suitable fastening means, described in detail below, and travelswith it to the open position shown.

While the swage dies are apart, the multi-axis gripper 155 is extendedto position the suture receiving end 7 of needle 9 within the opening392 as shown in FIG. 15(c) and FIG. 16(a). After positioning the suturereceiving opening 7 of needle 9 at the swage die opening 392, the swagedie 369, and suture alignment die 368, are moved toward needle 9 withthe resilient spring force present in spring 364 (FIG. 16(a)) that issufficient to enable the die 369 to grip and locate the suture receivingend 7 precisely against fixed swage die 361 without deforming the cavityof the suture receiving opening 7 formed therein. This is indicated atstep 17 in FIG. 3(a). Since the needle retaining pin 142 of multi-axisgripper 155 had been raised by downward external force on plunger 149,as described above at step 15b, the position of the needle is determinedby the grip of swaging dies 361 and 369. The motion of dies 368 and 369cause the face 368a of suture alignment die 368 to come in contact withthe corresponding face 362c of suture alignment die 362. The resilientforce causing this motion is forceful enough to compress spring 361c,and move funnel die 362 to the left, such that tang 362a is no longer incontact with cavity wall 361b. Dimensioning of dies 369 and 368 is suchthat this motion results in the formation of two funnel halves 362b and363 defining a smooth conical shape that is coaxial with the suturereceiving end 7 of needle 9. FIG. 15(d) shows the suture receiving end 7being gripped by the swage dies 361,369 prior to suture insertion. Notethat the exit diameter of the conically shaped funnel guide formed offunnel halves 362b and 363 is preferably equal to or greater than thediameter of the suture tipped end 258 and smaller than the diameter ofthe suture receiving end 7 of the needle 9, as shown in FIG. 15(e), sothat the tipped end 258 of the suture strand may be easily insertedtherein as indicated at step 18 in FIG. 3(a).

The control process 40 for inserting the free end 258 of the indefinitelength suture strand within the suture receiving end 7 of surgicalneedle 9, is illustrated in FIG. 3(d). First, a check is made to ensurethat the top or right gripper is at its predetermined position along itsrespective vertical guide rod as indicated at step 42 in FIG. 3(d).Next, as indicated as step 44 in FIG. 3(d), a check is made to ensurethat the needle 9 has been clamped in position within the swage dieopening 392 as described above. Immediately thereafter, the lead gripper232 is enabled to advance the suture material 255 for a short strokedistance of about 1 to 5 inches, and preferably, 1.9 inches, so that thetip 258 will advance precisely within the suture receiving end 7 for aswaging operation to take place at the swaging assembly 390. This isindicated at step 46 in FIG. 3(d). The status of the lead gripperservomotor that advances the suture material for the short stroke iscontinuously monitored, as indicated as step 47 in FIG. 3(d), to ensurethat the suture has been inserted within the suture receiving end 7 ofthe needle 9. While the lead gripper is inserting the suture during theshort stroke, the system performs a check at step 48 to determinewhether a time-out flag has been generated by the control systemindicating a time-out error. If a time-out flag has not been generated,the lead gripper has inserted the tipped end of the indefinite length ofsuture material within the suture receiving end of the needle (step 47)and the process continues. If the time-out flag is generated by thecontrol system as a time-out error, the process will be terminated andprompted for reinitialization at step 959.

FIG. 15(e) shows suture gripper 265a moved vertically to the insertionposition, which causes stiffened suture end 258 to enter funnel 362b and363, and be guided into the suture receiving cavity 7 of needle 9axially aligned therewith. Once the strand is inserted into the suturereceiving end 37 of the needle (step 18) as discussed above, theautomatic cutting of the indefinite length suture strand and theautomatic swaging of the suture receiving cavity occurs as indicated atstep 23 in FIG. 3(a).

The control process 80 for performing the automatic swaging of theneedle and the cutting of the indefinite length strand of suturematerial is described in detail with reference to FIG. 3(g).

As shown in FIG. 16(a), swage air cylinder 365 is extended to provideair pressure sufficient to actuate cam 375 to bear on lever 397 andthrust movable swage die 369 toward the fixed swage die to accomplishthe swaging of the suture receiving end of the needle placedtherebetween. This step is indicated at step 81 in FIG. 3(g). Airpressure is supplied to the swage cylinder 365 via ports 366,367 underthe control of the control system 99. As shown in the pneumaticschematic of FIG. 50(a), supply line 701 supplies pressurized airthrough suitable filter 702, through pressure monitoring devices 703aand 703b, and, through switching device 707d to provide the pressurizedair for controlling the swage cylinder 365 that provides the pressure toaccomplish swaging of needle 9 at the swage die opening 392. Note thatthe pressurized air supply line 701 is split into air supply line 701bthat supplies the air pressure for the swage cylinder 365.

The operation of the swage cylinder 365 is controlled by control lines704a,b which operate the switch 707d under the timing and control of thecontrol system 99. In the preferred embodiment, the moveable swage die369 comes to an automatic stop by a swage stop mechanism.

FIG. 15(f) shows the completed swage stroke. The swage die 369 has beendriven to a fixed stop by the swage cylinder, which exerted sufficientforce to deform the suture receiving end 7 of needle 9. As deformationtakes place, suture alignment die 368 further displaces funnel die 362,causing additional compression of spring 361c. In the preferredembodiment, the moveable swage die 369 comes to an automatic stop by aswage stop mechanism herein described. As shown in FIG. 16(b), movableswage die 369 and suture alignment die 368 are mechanically heldcoincident to each other by shouldered post 369a, the smaller diameterof which is a light press fit into the mating hold in die 369. Cap screw369c, with washer 369b retain the post in die 369. The larger diameterof post 369a, below die 369, extends through a light press fit hole infunnel die 368, so that the right hand swage and funnel dies are linkedto move together laterally during the swaging cycle. The lower portionof shouldered post 369a extends through funnel die 368, into groove390b, which is cross milled into swage assembly frame 390a. When theswage stroke is performed, the swage cylinder drives this die assemblyto the left until it is positively stopped by the lower portion of post369a striking wall 390c of groove 390b. This stalls air cylinder 365, sothat the stroke of the moveable right hand die assembly shown is alwaysthe same for repeating cycles of the machine.

At step 82 of FIG. 3(g), a check is made to determine if the swagecylinder had been fully extended to its predetermined position ascommanded by the control system 99. This is accomplished by a proximitysensors located at the swage assembly (not shown). If the swage cylinderis not fully extended, the cylinder continues to extend until it reachesits predetermined position. If the swage cylinder has been fullyextended, the swaging pressure used to accomplish the swaging ismeasured at step 83 in FIG. 3(g) by appropriate pressure transducerslocated in the air pressure lines (not shown).

The swaging pressure applied to the moveable swage die 369 can beadjusted by the control system 99. Thus, if a minimum swaging pressurehas not been achieved, the air pressure supplied to the swagingcylinders will be stepped up until the minimum predetermined pressure issupplied as shown as step 84 in FIG. 3(g).

The degree of swage compression imparted on the needle, and resultingstrength of grip by the needle on the suture, is adjusted by precisepositioning of the fixed die 361. As shown in FIG. 16(a), servomotor 345drives pulley 344 via timing belt 461, which rotates the swage adjustscrew 347. The pitch of the swage adjust screw 347 is selected to movesliding wedge 348 a small distance as sensed by proximity sensor 389interfaced with control system 99. The swage die 361 has a follower 343at the opposite end which bears on the wedge 348 to retract or advancethe position of the swage die 361 a precise distance proportional to themovement of the sliding wedge. Thus, the rotation of the swage adjustscrew 347 and motion of the sliding wedge 348, results in transversemovement of the swage die 361 to thereby finely adjust its fixedposition. For example, when a larger suture is to be swaged to a needle,the position of the fixed die 361 may be moved further away from thesuture drawing axis so as to provide the desired amount of deformationwhen the swaging pressure is applied to the needle by the movable swagedie 369. In the preferred embodiment shown in FIG. 16(a), the controlsystem 99 will send the appropriate signals to automatically direct theservomotor 345 to adjust the position of the swage adjust screw 347, andhence, the position of the fixed die 361, in accordance with thepull-out test values of the needle-suture bond as measured by automaticpull-test system as explained in further detail below. Specifically,appropriate signals may be sent to automatically direct the servomotor345 to adjust the rotational position of the swage adjust screw 347 inaccordance with stored statistical results of the pull-testing occurringat the pull-test station. Automatic pull-testing of the armed needle isdesirable to ensure that the upstream swaging dies are optimallypositioned to avoid over-swaging the needle-suture bond and hence,preventing the likelihood of clip-off, and, to avoid under-swaging theneedle-suture bond to prevent the chance of suture pull-out.

As indicated at step 85 in FIG. 3(g), immediately after swaging of thesuture to the needle, the left or bottom gripper 230 engages the suturestrand at the home position. A continuous monitoring is provided asindicated at step 86 in FIG. 3(g) to determine whether the bottomgripper has engaged the suture strand. While the left gripper engagesthe suture strand at the home position, the system performs a check atstep 88 to determine whether a time-out flag has been generated by thecontrol system indicating a time-out error. If the time-out flag isdetected, the process will be terminated and prompted forreinitialization at step 89. If a time-out flag has not been generated,then the left (or bottom) gripper 230 has engaged the suture strand atthe home position and two simultaneous operations are then performed asindicated at step 87 in FIG. 3(g). One operation is to cut the suturestrand at a position just above the location where the bottom gripper isgripping the indefinite length suture strand. The other operation is toopen the top gripper to release its grip of the swaged definite lengthsuture strand.

Cutting of the indefinite length suture strand is accomplished by theretractable cutter assembly 280, shown in FIG. 14 as suitably mounted ontip and cut carrier 100 and positioned slightly above the left oralternate gripper 230 so that the indefinite length suture strand 255will be gripped when the swaged strand is cut.

Cutter Assembly

FIGS. 17-19 illustrate in detail the cutter assembly 280. As shown inFIG. 17, the cutter assembly comprises overcenter linkage 282 having alink arm 283 pivotally connected at one end thereof. A pivotal locatorarm 285 is fixedly connected to link arm 283 at a second end thereof andis illustrated in FIG. 18 as substantially transverse thereto. The otherend of locator arm 285 is pivotally connected to a stationary guidemechanism 286. Note, that all pivotal linkages described herein aresimple pin linkages, the actuation of which creates the dwell moment forcutting the suture strand and obviates the need for complicated cam,slots, and sliding mechanisms.

As shown in FIG. 18, the stationary guide 286 is located in a planeperpendicular to the drawing axis of the suspended strand of material255, and is located a distance from the strand approximately equivalentto the length of locator arm 285. In addition, overcenter linkage 282,locator arm 285, and cutting blade 289 all lie in planes perpendicularto the drawing axis of the strand of material 255.

A retractable ball slide 288 is mounted on the stationary guide 286 andcoupled to overcenter linkage 282 for moving the overcenter linkage andblade 289 along the stationary guide 286 in the direction indicated byarrow "A" in FIG. 17 from a cutting position to a retracted positionshown in FIG. 18. As the ball slide 288 moves overcenter linkage 282 toa retracted position, the locator arm 285 is pivoted away from thestrand 255 and the blade 289 is retracted. Thus, when the cutterassembly 280 is in the retracted position prior to cutting of the strandand immediately thereafter, the blade 289 and locator arm 285 do notinterfere with the reciprocating motion of the grippers 232,230 alongthe drawing tower 220, nor do they come in contact with the suspendedstrand 255. In the preferred embodiment, pneumatic air cylinder 281enables reciprocating movement of the ball slide 288 along stationaryguide 286 as shown in FIG. 17.

As shown in the pneumatic schematic diagrams of FIGS. 50(c) and 50(d),supply line 701a supplies the pressurized to air cylinder 281 forenabling pneumatic reciprocating movement of the ball slide 288, andhence, the cutter assembly. The operation of the ball slide 288 iscontrolled by control lines 704c,d which operate the switch 707x underthe timing and control of the control system 99.

When cutting the strand of material 255, the retractable ball slide 288reciprocates in the direction toward the strand 255 indicated by arrow"B" in FIG. 18 to bring the overcenter linkage 282, cutting blade 289and locator arm 285 to the cutting position shown in FIG. 19. As theovercenter linkage 282 moves to the cutting position, the link arm 283translates the movement of the ball slide 288 into pivotal movement ofthe locator arm 285. Locator arm 285 is provided with a V-shaped supportnotch 287 which functions to engage and position the strand of material255 to be cut as the arm is pivoted into the cutting position. TheV-shaped notch also functions to support the strand on two sides of thestrand 55 while it is being horizontally cut on a third side. Thisenables clean, broom-free cuts especially of multi-filament suturematerial, which has a tendency to form a broom end when the strand isunder tension and is cut by scissors, or, when the multi-filament strandis sliced and otherwise, not properly supported.

The cutting blade 289 of cutter assembly 280 is fixedly mounted toreciprocating ball slide 288 at a slight angle relative thereto and in aplane parallel with that of the locator arm 285. In the preferredembodiment, a single action by the pneumatic air cylinder 281 willenable movement of the reciprocating ball slide 288 along stationaryguide 286. This consequently enables pivoting of locator arm 285 fromits retracted position (FIG. 18), so that V-shaped notch 287 supportsthe strand 255 at two sides thereof while a third side of the strandbears upon the cutting edge of blade 289 as the blade moves towards thesupported strand 255 traversing the drawing axis thereof. Thus, thestrand 255 is cut in a dwell moment of the locator arm after the locatorarm 285 has pivoted in the direction toward the blade 289 to the cuttingposition shown in FIG. 19. The blade 289 slices the strand of materialwhile it is held stationary by locator arm 285 by virtue of the angledorientation of the blade with respect to the axis of reciprocationillustrated in FIGS. 18 and 19. In the preferred embodiment, the sliceratio is 1:1, with the blade 289 angled at approximately 45 degreesrelative to the axis of reciprocation, so that the strand 255 is cut asthe blade 289 traverses the drawing axis.

After the strand of suture material is cut, the right or lead gripper232 is then actuated to release its grip on the definite length suturestrand 255 as indicated above at step 87 in FIG. 3(g). A continuouscheck is made, as indicated at step 89 to determine whether theindefinite length suture strand has been cut and whether the right orlead gripper 232 has released its grip of the cut suture strand. Untilthe indefinite length suture strand is cut and the right or lead gripperreleases its grip of the definite length suture strand, the system willperform a check at step 91 to determine whether a time-out flag has beengenerated by the control system indicating a time-out error. If atime-out flag has not been generated, the monitoring check continues(step 89). If the time-out flag is detected, the process will beterminated and prompted for reinitialization at step 959.

Automatic Pull-test Station

A test of the strength of the swaging bond of the armed needle indexedat the automatic pull-test station 300 may be performed as described indetail below and in further detail in copending patent application Ser.No. 08/181,601 (attorney docket No. 8923) assigned to the same assigneeof the present invention and incorporated by reference herein. Automaticpull-testing of the armed needle is desirable to ensure that pull-testrequirements are met. Specifically, as described in detail below, eithera minimum pull-test, indicated as step 19b in FIG. 3(a), or, adestructive pull-test, indicated as step 19c in FIG. 3(a) is beingperformed at the pull-test station 300. A bit status check is alwaysmade at step 19a to determine if a destructive pull-test is to beperformed in the current machine cycle.

The automatic pull-test assembly 300 for accomplishing automaticpull-testing of an armed surgical needle generally comprises a load cellmounting assembly 330 for mounting a load cell 335 which functions toreceive the armed needle 9 from the multi-axis gripper 155 which isindexed thereto as shown in FIGS. 20 and 21(a). A needle releaseassembly 315 is provided for relaxing the armed needle from the grip ofthe multi-axis gripper 155. Pull-test fence assembly 340 is provided toprevent the armed needle 9 from tipping over or becoming misaligned whenthe armed needle is relaxed. Suture gripping assembly 370 containingretractable gripper arms 325a,b for gripping the suture 255 during thepull-tests, and which are connected to the weighted slide block assembly372 for performing the pull-test is provided as shown in FIG. 20.

As shown in FIGS. 20 and 21(a), an armed surgical needle 39 is retainedby a multi-axis gripper 155 and, in the manner described above, isindexed to the automatic pull test station 300 by the rotary swage dial150 partially illustrated in the FIG. 20. To position the armed needle 9in the load cell 335, the multi-axis gripper is extended from the swagedial 150 so that the end portion of needle 39 is positioned above acorresponding receiving blade 336 of the load cell 335 as shown in FIG.21(a).

FIG. 22 illustrates a top view of the load cell mounting assembly 330with load cell 335 mounted thereon. In the preferred embodiment, loadcell 335 has mounted thereon four (4) thin needle supporting blades336a,b,c,d for supporting the suture receiving end portion 37 of varioussize surgical needles with the suture material 255 depending therefrom.For instance, load cell needle supporting blade 336a labelled "1/0"accommodates a larger sutures having a diameter of approximately0.017+/-0.001 inches; load cell needle supporting blade 336b labelled"2/0" accommodates sutures having a diameter of approximately0.014+/-0.001 inches; load cell needle supporting blade 336c labelled"3/0" accommodates sutures having a diameter of approximately0,011+/-0.001 inches; and load cell needle supporting blade 336dlabelled "4/0" accommodates a smaller suture with a diameter ofapproximately 0.009+/-0.001 inches in the preferred embodiment.Depending upon the batch of surgical needles currently being pulltested, the appropriate needle supporting blade 336a,b,c,d will bepositioned to receive the needle from the multi-axis gripper. Knob 339located centrally on top of the load cell 335 may be manually operatedto rotate the load cell and position the correct sized suture receivingblade prior to carrying out automatic pull-testing. Additionally, theload cell 335 may be laterally positioned by moving slide handle 338 andconsequently load cell platter 337 towards or away from the sutureneedle indicated by the arrow in FIG. 22.

The multi-axis gripper 155 is initially positioned so that the endportion of armed needle 9 is supported by the appropriate needlesupporting blade 336 (e.g. blade 336b). FIG. 33 is a front crosssectional view illustrating the suture receiving end portion 7 of needle9 resting upon the needle supporting blade 336b with the suture strand255 threaded between the suture receiving guide 334.

The control process 50 for performing non-destructive suture pulltesting of the armed surgical needle 9 is described in detail withreference to FIGS. 3(e), 21(a), and 21(b).

After positioning the multi-axis gripper as heretofore described,gripper arms 325a,b of suture gripping assembly 370 are extended from aretracted position to grip the suture strand 255 slightly below theneedle supporting blade 336 of load cell 335 as shown in FIG. 21(a) andas indicated as step 51 in FIG. 3(e). A gripper actuator 372a isprovided for opening and closing gripper arms 325a,b, as shown in FIG.20, and is controlled by control system computer 99.

As shown in the pneumatic schematic diagram of FIG. 50(b), supply line701a supplies pressurized air that has been filtered and monitored byfilter 702 and monitoring device 703a, respectively, and, throughswitching device 707f to provide the pressurized air for opening andretracting the gripper arms 325a,b of suture gripping assembly 370.Control signal lines 704a,b of control system 99 control the timing andpositioning of switching device 707f as well as the opening and closingof the gripper arms 325a,b of retractable suture gripper actuator 372athat control gripper arms 325a,b.

FIGS. 20 and 21(a) illustrate the slide block assembly 372 that iscomposed of slide rods 372b,c that are connected to a lower slide block372d. Slide block 372d includes a slide finger 372e upon which aircylinder piston rods 374a and 379a, of respective air cylinders 374,379,apply respective upward and downward forces depending upon the type ofpull-test that is to be performed. As shown in FIG. 21(a), piston rod374a is shown in an extended position providing an upward force thatsupports slide finger 372e and consequently maintains slide block 372dof slide assembly 372 at a fixed vertical position.

Slide block 372d is counterweighted to a net downward weight of 2 to 5ounces by appropriately sized counterweight 376 that acts through cable373, around pulley 377, and through attachment point 372h. Thiscounterweight 376 acts to pull upward on slide block 372d at theattachment point 372h.

To accomplish the non-destructive pull test, piston rod 374a of aircylinder 374, mounted on the mechanism frame 371 and controlled bysystem computer 99, is retracted from its extended position (FIG. 21(a))supporting the slide finger 372e as shown in dashed line in FIG. 21(b),by reversing its air supply (not shown), to the position shown in thefigure. This is indicated as step 52 in FIG. 3(e) and occurs immediatelyafter the gripper arms 325a,b grip the suture. The piston rod 374a isthus retracted to remove the upward force on slide finger 372e, as shownin the FIG. 21(b), to thereby impose the counterbalanced net weight of 2to 5 ounces of slide block 372d on the swage attachment means of suture255 in needle 9, in the direction of arrow "A". Accuracy of this systemis enhanced because slide block 372d, suspended on slide rods 372b,c,are mounted in low friction ball bushings, 372f and 372g, that arepressed into slide mount 371, thereby imposing minimal mechanical dragon the system.

As shown in the pneumatic schematic of FIGS. 50(a) and 50(b), supplyline 701a supplies filtered and regulated air under pressure toswitching device 707f for controlling the air cylinder 374 that providesthe force for maintaining the position of slide block assembly 372 onslide block 371, and releasing the slide block therefrom. The operationof the air cylinder 374 is controlled by control lines 704a,b whichoperate the switch 707f under the timing and control of the controlsystem 99.

Simultaneous with or momentarily before the slide assembly 372 isreleased, the needle release assembly 315 is actuated to enablemulti-axis gripper 155 to disengage its grip on the armed needle 9.Releasing the armed needle from the grip of the gripper 155 is necessaryto ensure that it is firmly positioned on the load cell needlesupporting blade 336. Moreover, to provide an accurate pull-test, theneedle must be released so that there is no existing upward force thatwould cause false results. The releasing of the armed needle for testingis indicated at step 53 in FIG. 3(e) and described above with respect toFIG. 3(b). The dwell time for minimum pull-testing is short, preferablyranging in milliseconds, as indicated as step 54 in FIG. 3(e).

As shown in FIG. 20, needle release assembly 315 comprises needlerelease solenoid 324 that is actuated to extend pusher 326 into pivotallever arm 327. Pivotal lever arm 327 pivots about pin 328 to depressplunger 149 of the multi-axis gripper 155 at one end 329 thereof.

To prevent the armed needle 9 from becoming misaligned or from tippingover after the multi-axis gripper 155 releases its grip on the needle, aneedle fence assembly 340 is provided. As shown in FIG. 20, the needlefence assembly 340 includes vertical fence plate 342 which can beadjusted to lie flush against the gripper 155 to retain the armed needlein an upright position. Adjusting the lateral positioning of thevertical fence plate 342 is accomplished by moving slide handle 343 foran appropriate distance as shown in FIG. 20. In the preferredembodiment, the configuration of the face of the vertical needle fenceplate 342 (not shown) may be changed to accommodate the configurationsof different size needles.

In the preferred embodiment of the minimum and destructive pull-testsystems shown in FIGS. 20-23, the load cell 335 and the needle supportblades 336a,b,c,d thereof comprise a piezoelectric transducer thatmeasures the force applied by the suture gripping assembly to theneedle-suture assembly 9. The transducer load cell 335 may be interfacedwith the control system computer 90 by conventional means as shown inFIGS. 20 and 22, and, in the preferred embodiment, is a 1000 gramtransducer manufactured by Techniques Co. (Model No. GS-1K). Thedetermination of whether the minimum-pull test has passed or failed ismade at step 56 shown in FIG. 3(e).

If the test is successful, i.e., the suture meets the minimum pull-testrequirements, the needle is re-gripped by the multi-axis gripper 155 asindicated at step 57 in FIG. 3(e). This is accomplished by deactuatingthe needle release solenoid 324 (FIG. 20). which releases the force onplunger 149. Next, as indicated at step 58 in FIG. 3(e), the suturegrippers 325a,b are retracted to their open position to release theirgrip on the suture 255. At step 59, a flag indicating that the minimumpull-test was successful and that the armed needle may be conveyeddownstream for packaging thereof, is set for later use by the controlsystem. Furthermore, if the suture pull-test was successful indicatingthat the upstream swage was good as shown as step 61a in FIG. 3(e), thena counter is incremented to reflect this at step 6lb. A current count iskept of all the needles that are pull-tested so that for every n^(th)needle, 50 in the preferred embodiment, a destructive pull-test may beperformed.

It should be understood that only the destruct forces applied to thesuture 9 and measured by the load cell transducer 335 during thedestructive pull-testing are stored for statistical purposes or forreal-time monitoring during a swage die setup routine that may takeplace when a new batch of surgical needles are to be swaged. Forinstance, if the destructive pull-tests fail and the forces measured bythe transducer are determined to be at the low end of a predeterminedrange, then the control system computer 99 will acknowledge this andprompt the operator to perform a die setup routine to re-adjust thelocation of the fixed die of the upstream swaging assembly 390 toincrease the force provided by the swage stroke. Alternatively, thecontrol system computer 99 may send the appropriate signals to theupstream swaging assembly 390 (FIG. 16(a)) during run-time causing afixed swaging die to be advanced an incremental amount toward themoveable swage die, resulting in subsequent swages being stronger. Ifthe destructive pull-test passes, i.e., the forces measured by thetransducer are determined to be above the minimum and below an upperlimit, then no upstream swage die adjustment need be made.

To prepare for the next armed needle to be pull-tested, the slideassembly 372 and retracted gripper arms 325a,b are pushed back up theslide mount 371 to their unloaded position by an appropriate upwardforce supplied by the air cylinder 374 and piston rod 374a as controlledby the control system computer 99 and as indicated as step 62 in FIG.3(e). At this time, another flag may be sent for storage to the controlsystem computer that indicates that the pull-test performed on theparticular needle 9 was successful and that the armed needle may beconveyed downstream for packaging thereof. A continuous check is made,as indicated at step 63 in FIG. 3(e), to determine if the grippers325a,b have reached their home position. Until the gripper 325a,b andslide block 372 are pushed back to their home position, the system willperform a check at step 64 to determine whether a time-out flag has beengenerated by the control system indicating a time-out error. If atime-out flag has not been generated, the monitoring check continues(step 63). If the time-out flag is detected, the process will beterminated and prompted for reinitialization at step 959. If the suturefails the minimum pull-test, i.e., if the suture 255 is dislodged fromthe surgical needle 9 as a result of the controlled release, a NEEDLEREJECT bit is set in the control system computer 99 as indicated at step65b in FIG. 3(e) so that the disarmed needle 9 will be ejected at thepull-test station. As indicated at step 37 in FIG. 3(a), the dislodgedsuture strand 255 will subsequently be sucked into a vacuum assembly andthe needle 9 will be ejected by a needle stripper blade 385 of theneedle assembly 380 shown located next to the needle 9 in FIG. 21(a).Alternatively, the suture strand may be ejected by a suitable blast ofair provided by an air jet 292. As shown in the pneumatic schematic ofFIGS. 50(a) and 50(b), supply line 701a supplies filtered and monitoredair under pressure to the switching device 707i for controlling the airjet 292 that provides the blast of air for ejecting the suture strandthat has become dislodged from the needle after failing a minimumpull-test.

As shown in FIG. 24, needle stripper solenoid 382 will be actuated by acontrol signal output from the control system computer 99 to extendneedle stripper blade 385 mounted on a slide block 383. Thus, when theneedle is in its relaxed state on the multi-axis gripper 155 and theminimum pull-test fails, the needle stripper blade 385 is extended toremove the needle from the gripper as indicated at step 65a in FIG.3(e). The needle will fall and be collected by appropriate collectionmeans (not shown) located at the pull-test station.

As previously mentioned, the automatic pull-test assembly 300 is used toperform a minimum pull-test upon every armed surgical needle indexedthereto prior to automatic packaging thereof. A destructive pull-testingof the armed surgical needle is performed at every nth needle indexedthereto. The purpose of performing a destructive pull-test is to set theswage dies located at the upstream swaging station for correct maximumswage pull-out value. This is by necessity a destructive test, and thetest frequency, which is programmable, is set high enough to maintaincontrol of the operation, but low enough to avoid excessive productwaste. In the preferred embodiment, this frequency is set at every 50thneedle, but can be modified to be every 75th or 100th needle.

Another purpose of the destructive pull test is to aid in installing anew swage die set during a changeover procedure, which is a procedurethat is used to prepare the needle sorting and swaging apparatuses(swage dies) for processing a new batch of needles when they are of adifferent size from a previously processed batch. Contrary to thenon-destructive pull-test described above, the pull-test apparatus isprogrammed for 100% destructive test of a swaged needle, while theswaging assembly is operating and feeding the armed needles to thepull-test station. The die adjustment system at the upstream swagingassembly will receive a signal from the transducer load cell 335, ateach machine cycle, and immediately perform a correct adjustment of theswage dies.

Destructive test pull-out values are recorded in the system computer 99and are used to compute statistical process control information which isfed back to the machine operator through display screens.

Destructive pull testing of the armed surgical needle 9 is accomplishedsimilarly as described herein above with respect to the minimum pulltest. However, the fundamental difference is that a fixed mechanicalstroke that is great enough to pull the suture out of the needlereplaces the minimum 2 to 5 ounce force of the minimum pull test. Itshould be noted that if the knot detector 256 at the swaging station 200determines that the length of suture strand is defective, the controlsystem 99 informs the pull-test station to automatically perform adestructive pull-test (step 19c) on the suture having the bad strand.Thus, the needle 9 and the defective suture strand may be rejected inthe manner described below however, however the measured force valueswill not be used for statistical control purposes and an updatablecounter (step 79c) will not be incremented as it is for the otherpull-tests.

The control process 70 for performing destructive pull-testing of thearmed surgical needle 9 is described in detail with reference to FIG.3(f). First, gripper arms 325a,b of suture gripping assembly 370 areextended from their retracted position to grip the suture strand 255slightly below the needle supporting blades 336 as described above andindicated as step 71 in FIG. 3(f). Piston rod 379a of second aircylinder 379 located opposite air cylinder 374, is programmed to providea fixed stroke against slide finger 372e from a non-actuating positionshown in FIG. 21(a) to the position shown in FIG. 21(c). This results inthe vertical displacement of slide finger 372e from a position shown bythe dashed line to a position shown by the solid line. This furtherresults in a downward force upon slide block 372d, which, through sliderods 372b and c, moves slide assembly 372, including grippers 325a,b andsuture 255, in the direction of the arrow "B" as shown in FIG. 21(c) asindicated as step 72 in FIG. 3(f).

AS shown in the pneumatic schematic of FIGS. 50(a) and 50(b), supplyline 701a supplies pressurized air that has been filtered and monitoredto the switching device 707h to provide the pressurized air forcontrolling the air cylinder 379 that provides the destruct forceagainst slide finger 372e for pulling the slide block assembly 372 anamount necessary to dislodge the suture from the needle. Air pressure tocylinder 379 is set high enough to always pull suture 255 out of needle9. This stroke is limited by the top portion 372j of slide assembly 372striking the top of stationary block 371. The operation of the destructair cylinder 379 is controlled by control lines 704a,b which operate theswitch 707h under the timing and control of the control system 99.

Again, to provide an accurate destructive pull-test, the needle 9 mustbe released from the grip of the multi-axis gripper 155 so that there isno existing upward force that would cause false results. Thus, the armedneedle is released for testing as indicated at step 73 in FIG. 3(f).

The force necessary to accomplish the destructive pull-test is measuredby the piezoelectric load cell transducer 335 as discussed above. Thismeasurement is continuously made, i.e., anywhere upwards of 100 pressurereadings may be taken, as indicated at step 74a in FIG. 3(f). When themeasurement is finished, as indicated at step 74b in FIG. 3(f), themaximum value of the destructive force is calculated from theapproximately 100 readings, and finally stored in the computer 99 forstatistical process control at step 75. Since the suture pull-test wasdestructive, a NEEDLE REJECT bit is set in the control system computer99 as indicated at step 76a in FIG. 3(f) so that the disarmed needle 9will be ejected at the pull-test station.

If it is determined by the process control algorithm (not shown) thatthe destructive pull-test forces as measured by the transducer load cellare lower than a predetermined range of pull-test values, the controlsystem computer 90 will send out appropriate control signals to increasethe swaging die stroke applied when swaging the suture to the needle atthe upstream swaging station 200. If it is determined that thedestructive pull-test forces as measured by the transducer load cell arehigher than the predetermined range, the control system computer 99 willsend out appropriate control signals to the upstream swaging assembly tomove a fixed swage die a small incremental distance away from thesuture, thereby decreasing the swaging pressures applied when swagingthe suture to the needle.

Since the destructive pull-test necessarily results in the suture strandbeing dislodged from the needle 9, the needle is removed from the gripof the multi-axis gripper 155 by the needle stripper blade 385 asindicated at step 76b in FIG. 3(f), and as described above with respectto step 65a in FIG. 3(e). Additionally, the gripper arms 325a,b areretracted to their open positions. As indicated at step 77a in FIG.3(f), air cylinder piston rod 379a is retracted and air cylinder 374provides the upward force to restore the gripping assembly 370 and slideblock assembly 372 back to their normal position in preparation for thenext pull-test.

Simultaneously therewith, the multi-axis gripper is then reverted backto its needle gripping position at step 77b, as will be described indetail below. While multi-axis gripper is enabled to its gripping state,a continuous check is performed at step 79a to verify when the needlegripper has closed. Simultaneously therewith, the system will perform acheck at step 79b to determine whether a time-out flag has beengenerated by the control system indicating a time-out error. If atime-out flag had not been generated, then the needle gripper hasclosed. If the time-out flag is generated by the control system as atime-out error, the process will be terminated and prompted forreinitialization at step 959. Since a current count is kept of all theneedles that are pull-tested, the counter is incremented at step 79c.

Swage Die Setup Procedure

The die setup procedure utilizes the swage bond values obtained from asample of needle suture assemblies pull-tested at pull-test station 300,to adjust the positioning upstream swage dies. As mentioned above, thisprocedure is usually run off-line at the beginning of a batch run orneedle changeover procedure, or, it can be run as part of areinitialization or error correction routine.

Essentially, during the die setup procedure, the swage assembly producesa sample of 25-30 and preferably 28 needle-suture assemblies forconveyance to the upstream pull-test station. In the manner explainedabove, all of the sample needle-suture assemblies are destructivelypull-tested and the needle-suture destruct values, as measured by thetransducer, are stored, analyzed, and compared to a predetermined valuethat corresponds to either a minimum pull-test force, to an acceptablepredetermined maximum destruct value, or to combinations thereof asimplemented by the process control algorithm (not shown). After eachsuccessive pull-test, the position of the fixed swage die of theupstream swaging station will vary in accordance with the destructvalues obtained and the control algorithm that is implemented to performthe comparisons. It is understood that minimum and maximum pull-testvalues will vary in accordance with the type of surgical needle and theattached suture being processed.

After either of the pull-test routines of FIGS. 3(e) and 3(f) areperformed at the pull-test station 300, and the swage/cut/monitorprocess of FIG. 3(g) is performed at the swaging station 200, and afterthe next needle is handed off to the multi-axis gripper at station 100or after the needle is handed off to the suture wind and packaging dialat station 600, the control system 99 enables each multi-axis gripper torevert to its respective needle or needle-suture assembly engagingstate. Thus, as indicated in the RETRACT MAG (Grip needle) steps31a,b,c,d in FIG. 3(a), the process of biasing pin 142 from itsnon-engaging position back into its needle engaging position as shown inFIG. 11(b) is initiated.

The control process 60 for enabling each multi-axis gripper 155 tore-grip each needle after processing at each respective station isillustrated in FIG. 3(h). First, at step 63, the control system 99enables the cam solenoid 143 to retract from the plunger 149 as shown inFIG. 11(b), so that pin 142 of each multi-axis gripper is biased backinto its needle engaging position. While the cam is being retracted, acontinuous check is performed at step 64a to verify when the motoroperating the cam solenoid has stopped running. If the cam has not beenretracted, the system will perform a check at step 64b to determinewhether a time-out flag has been generated by the control systemindicating a time-out error. If a time-out flag has not been generated,then the cam solenoid has been fully retracted (step 64a). If thetime-out flag is generated by the control system as a time-out error,the process will be terminated and prompted for reinitialization at step959.

After each multi-axis gripper regrips a respective needle orneedle-suture assembly (steps 31a,b,c,d) while extended at a respectivestation, the multi-axis gripper 155 is retracted back from its extendedposition to its initial position on the rotary swage dial 150, asindicated at step 20 in FIG. 3(a). To retract each multi-axis gripperfrom its extended position, the cam dial plate 125 is rotated in thecounterclockwise direction for approximately 45°-55° degrees withrespect to the swage plate 110, forcing cam follower 165a in itsrespective cam track 160a to move to its retracted position (FIG. 8(a)).When cam dial plate 125 rotates counterclockwise with respect to swagedial 110, each multi-axis gripper 155 is retracted within its respectivecam track. Thus, the system is designed so that after needle hand-off atstation 100, and needle-suture assembly insertion at station 600, andafter respective processing at stations 200 and 300, each multi-axisgripper may then be retracted as indicated at step 20 in FIG. 3(a),prior to being indexed to the next successive processing station.

After a needle is engaged by the multi-axis gripper 155 at eachrespective workstation and retracted after hand-off or processing asdescribed above, the rotary swage dial assembly and cam dial assembly125 are both rotated counterclockwise to index the needle to the nextsuccessive workstation as indicated at step 39 in FIG. 3(a).Specifically, to index the needle to another station, both swage dialplate 110 and cam dial plate 125 are rotated together for approximately90° degrees to position each multi-axis gripper at the next successivestation. For example, when the cam dial plate 125 and the swage dialplate 110 are simultaneously rotated 90 degrees counterclockwise in FIG.10, the gripper 155 that had received the needle at station 100 is nowindexed to a position at station 200 for swaging a suture thereto.Similarly, the needle having the suture attached thereto at station 200is indexed to the position at station 300 for pull-testing thereof.Additionally, after pull-testing, the armed needle engaged by amulti-axis gripper at pull-test station 300 will be indexed to theneedle/suture load to package station 600 for discharge thereof. Afterrotating the rotary swage dial 150 to index each multi-axis gripper toits successive workstation at step 39, the control system performs acheck at step 39a to determine whether the motor controlling therotation of the rotary swage dial 150 for the indexing function (step39) has finished. A continuous check is made at step 39b to determinewhether a time-out flag has been generated by the control system 99indicating that the motor indexing has not occurred within apredetermined time. If a time-out flag has not been generated, the motorhas stopped driving the swage dial 150 in the allotted time. If themotor does not perform the indexing of the dial within the allottedtime, a time-out flag is generated by the control system indicating anerror, and the process will be terminated and prompted forreinitialization at step 959, to be described in detail below.

After the right or lead gripper 232 has released its grip of the cutsuture strand, the control system 99 enables swage cylinders 361,369 tobe positioned apart while enabling pin 142 of the multi-axis gripper 155to engage the armed needle as described above with respect to step 3lbin FIG. 3(a). Simultaneously therewith, as indicated at step 27 in FIG.3(a), the control system 99 commands the left and right servomotors236,238 to reciprocate the respective left and right grippers with theright or lead gripper reciprocating to the home position in anon-engaging position along the right guide rod, and the left or bottomgripper reciprocating to the suture insertion position along the leftguide rod while drawing the indefinite length of suture material 255 forthe long stroke as described above with respect to step 16. The processof advancing suture material 255 by alternating left and right grippersat each cycle eliminates the recycle or return time for retaining thegripper to the original position. This makes faster machine speeds andhence, higher production rates possible.

Immediately after the lead gripper advances the long stroke distance andthe alternate gripper reciprocates to its home position and comes to ahalt, a portion of the suture material 255 may be heated (tipped) asindicated as step 35a in FIG. 3(a). Heating of the suture under tensionand the subsequent cooling thereof will stiffen the suture material forcutting and aid in the subsequent insertion of the tip of the materialwithin the suture receiving end 7 of the surgical needle. In thepreferred embodiment, the control system computer 99 controls theduration and temperature of a heat pulse that is applied to the suturematerial so that it is adequately heated and will have sufficient timeto cool before the cutting operation. The operation of the tippingassembly 290 mounted on tip and cut carrier 180 is explained in greaterdetail in copending patent application Ser. No. 08/181,595 (attorneydocket No. 8924) assigned to the same assignee of the present invention.As described therein, the tipping assembly 290 is located at a positionthat is located slightly below the alternate gripper, for e.g., leftgripper 230, so that when the suture material 255 is advanced the shortstroke distance for insertion within the needle 9, the tipped portion ofmaterial 255 that had been subject to the heated air advances to aposition just above the home position of the left gripper 230 andadjacent the cutter assembly 280. Then, the left gripper 230 (lowergripper) is actuated to grip the material 255 at or below the tippedportion, i.e., the portion of the suture material heated by tippingassembly 290 as shown in FIG. 13, and the cutter assembly 280 isactuated to cut the tipped portion of the suture material 255 so thatthe left gripper 230 is now gripping an indefinite length suture strand255 having a tipped end 258 for the next suture draw/insert cycle.

After accomplishing the optional step of heat tipping a portion of thesuture material (step 35a), a cool air jet 291 appropriately positionedat the drawing tower 220 may be provided to apply a blast of cool air tothe tipped portion of the suture material as shown at step 35b in FIG.3(a). As shown in the pneumatic schematic of FIG. 50(a), supply line701a supplies pressurized air through suitable filter 702, pressuremonitoring device 703a and through switching device 707e to provide anair jet pulse for cooling the heated (tipped) portion of the suturestrand. The operation of the air jet is controlled by control lines704a,b which operate the switch 707e under the timing and control of thecontrol system 99.

Automated Packaging Machine

During the process of arming surgical needles at the needle threadingand swaging dial 150, as described above, a simultaneous packagingprocess occurs at the suture wind and packaging machine 500. In essence,the rotary packaging turret 500 comprises rotary dial member 514, isindexed forwardly in the direction of arrow "B" in FIG. 1 such that eachtool nest located on dial 500 is adapted to be advanced in succession toa number of workstations located about the periphery of the rotaryturret 500.

FIG. 4(a) is a general flow chart illustrating the automaticneedle-suture packaging processes 700 operable under the control of thecontrol system 99 of the instant invention. To the extent possible, eachprocess performed at each workstation as illustrated in FIG. 4(a) willbe described in the sequential manner as illustrated in the figure.

The foregoing indexing motions of the rotary turret 500 are implementedin order to produce a completed suture package and are correlated witheach other through the program-controlled operation of the machine suchthat the dwelling-time periods at each of the respective workstations iscomputed to allow sufficient time for the preceding step to be completedat the preceding workstation or workstations. This enables a smooth andcontinuous flow of product from the automated packaging machine andprovide for high-speed and efficient manufacturing cycles.

Suture Wind And Package Dial

As shown in FIGS. 25 and 26 the rotary suture wind and package turret500 is essentially constituted of a circular disc-shaped dial 514 havinga plurality of tool nests 516 located thereon in uniformly spacedcircumferential array on the upper surface 518 of the rotary packageturret 500, and with each tool nest extending radially outwardly of theperiphery thereof.

Generally, as shown in FIG. 25, there are provided eight tool nests 516arranged at 45° angular spacings from each other about the circumferenceof the dial 514. As shown in detail in FIGS. 26 through 28 of thedrawings, each tool nest 516 consists of a housing 520 which is fixedlymounted on the upper surface 518 of the disc-shaped dial 514 of rotarydial 500, and includes a portion 522 radially outwardly projecting fromthe circumferential edge 524 of the disc member 514 which is operativeto receive and support flat-bottomed injection-molded plastic traysutilized in the forming of suture packages containing surgical needlesand attached sutures, as described hereinbelow.

As illustrated in FIGS. 26 through 28(a), each of the tool nests 516comprises a housing or block 520 fixedly mounted through suitablefasteners to the upper turret surface 518 proximate the peripheral outerrim or edge 524 of the dial 514 of turret 500. Each housing 520 includesa horizontal radially extending central bore 526 having a shaft 528supported on bearings 529a and 529b rotatably journaled therein, withthe shaft being connected to a suitable drive source (as subsequentlydescribed). Cam rollers 530 mounted at the radially inner end 532 of thehousing 520 are adapted to contact a cam plate dial 533 extending overthe dial surface 518 during the rotation of the turret 500 for purposesas described in more specific detail hereinbelow. At the radially outerend 534 of the housing 520, there is provided structure for supportingthe components for forming a suture package, the latter initiallycomprising a generally flat injection-molded tray 420 for receiving andretaining therein a plurality of surgical needles and attached sutures;for example, as illustrated in FIG. 46 of the drawings, and with anapplied tray 420 cover as shown in FIG. 47, as disclosed in U.S. Pat.No. 5,230,424 entitled "Multi-Strand Suture Package and Cover-Latching",the disclosure of which is incorporated herein by reference.

The radially outer structure of the housing 520 for initially mountingthe plastic suture tray 420 includes a generally rectangular,round-cornered and vertically extending plate member 536 of which theouter peripheral surface 538 forms a cam surface, employed for asuture-winding purpose as described hereinbelow, and with the platemember 536 being secured to the radially outer end of the shaft 528 forrotation therewith. Mounted on the front surface of cam plate member 536is a plate 540 having a radially outwardly facing, vertically-orientedsupport surface or platform 542 possessing projecting guide pins 544 forthe positioning and mounting thereon of an injection-molded plastic tray420 adapted to be supplied with surgical needles and attached sutures.The cam plate member 536 and the plate 540 for supporting the suturetray 420 are connected with each other so as to be secured againstrelative rotation, both being jointly rotatable about the longitudinalhorizontal axis 528a of the shaft 528 extending through the block orhousing 520. However, the plate 540 for mounting the tray 420 islinearly displaceable relative to the cam plate member 536 through theprovision of cooperating slide guides 546 located between theseelements. These slide guides 546 are disclosed in more extensive detailin the enlarged fragmentary illustration of FIG. 28(b), where they areillustrated as mating guide rails 546a and 546b, and are provided tofacilitate the successive insertion of an array of surgical needles intothe tray 420 which is mounted on the guide pins 544 extending from thesupport surface 542 of the plate 540 of the tool nest 516.

The external configuration of both the cam plate member 536, i.e. itscamming surface 538, and the support plate 540 is substantially inconformance with the outer shape of the suture tray, although larger inexternal dimensions than the latter.

Further details of the automatic packaging system can be found incopending patent application Ser. No. 08/181,626 (attorney docket No.8925) assigned to the same assignee of the present invention andincorporated by reference herein.

The automated process 700 of packaging needle-suture assemblies ascontrolled by the control system 99 of the invention, are generallyillustrated in FIG. 4(a). As shown therein, each process performed ateach station occurs approximately simultaneously to ensure efficientoperation as the packaging dial 500 rotates.

(1) The first of the successive workstations located about the rotarysuture wind and package dial 500, is the package load station 400 shownin FIG. 4(a) as step 710. At the package load station 400, empty suturetrays 420 are positioned on the radially outwardly facing platform orsupport surface 542 of the plate 540 on tool nest 516, and retainedthereon by means of the guide pins 544 extending through positioningapertures in the tray 420 so as to be in a generally verticalorientation relative to the horizontal plane of rotation of the rotarydisc member 510. Suitable grippers of a tray 420 feeding apparatus ormechanism (not shown), may be provided to supply empty tray 420 tosuccessive plates 540 and position the tray 420 thereon. The grippersmay obtain individual tray 420 from a suitable supply source, such as astack of trays 420, and position the tray 420 one each on successiveforwardly indexed platforms 540 of the tool nests 516. Alternatively, inthe absence of gripper mechanisms the tray 420 may optionally bemanually positioned on the guide pins 544 of platform 540 such that therear surface of each tray 420 contacts the support surface or platformin a flat, surface-contacting relationship so as to be firmly mountedthereon.

The control process 710 for package loading at station 400 isillustrated in FIG. 4(b). The first step indicated as step 713 in FIG.4(b), is to turn on the air and vacuum supply for the commerciallyavailable vacuum gripper, indicated as element 759 in FIG. 50(c), thatgrips each empty package tray 420 from the stack and loads it onto theplate 540, is operational. Additionally, the air and vacuum supply issupplied to a manipulating gripper arm, indicated as element 758 in FIG.50(c), for extending the vacuum gripper 759 to grasp an empty packagetray 420 prior to placing an empty package tray 420 onto the plate 540.

As shown in the pneumatic schematic diagram of FIG. 50(c), supply line701 supplies air through suitable filter 702, and through pressureregulator 703cbefore being split into supply lines 701aand 701b. Airsupply line 701b supplies the pressurized air through another pressuremonitoring device 703d to a vacuum pump 705a which provides the vacuumfor the vacuum gripper 759 to grasp each empty package tray 420 byvacuum suction. The operation of the vacuum gripper 759 is controlled byswitch 707j under the timing and control of the control system 99. Averification is made at step 714a of FIG. 4(b) to determine if thevacuum has been turned on. The system will perform a check at step 714bto determine whether a time-out flag has been generated by the controlsystem indicating a time-out error. If a time-out flag has not beengenerated, then the vacuum is on (step 714a). If the time-out flag isgenerated by the control system as a time-out error, then the cycle jamprocedure will be implemented at step 775 shown in FIG. 4(b).

Additionally, air supply line 701a provides the air supply for thegripper arm 758 utilized to manipulate, i.e., extend and retract, thevacuum gripper 759. The operation of the package load gripper arm 758 iscontrolled by control lines 704c,d which operate the switch 707k underthe timing and control of the control system 99. If it is determinedthat the air supply is off or not at the correct operational level asmonitored by monitoring device 703c, then the cycle jam procedure willbe implemented at step 775 shown in FIG. 4(b) and explained in furtherdetail below.

At step 715 in FIG. 4(b), the control system 99 performs a check on thestack of empty package trays (not shown) to ensure that the stack levelis not too low. If it is determined that the stack of package trays 420is too low, then the control system will check if the package traycounter (not shown) is equal to zero (0) at step 717 in FIG. 4(b). Ifthe counter for the stack of trays 420 is not equal to zero (0) thecounter is decremented at step 719 and the extend stack release signalis given at step 721 to enable a release lever to extend and enable thepackage gripper arm to access and vacuum grip the next empty packagetray 420 from the stack as shown at step 723.

While the stack release lever is being extended, the system will performa check at step 722 to determine whether a time-out flag has beengenerated by the control system indicating a time-out error. If atime-out flag has not been generated, then the release lever has notfully extended (step 723). If the time-out flag is generated by thecontrol system as a time-out error, then the cycle jam procedure will beimplemented at step 775 shown in FIG. 4(b).

As shown in FIG. 4(b) once the package load gripper arm 758 has reachedits extended position and has grasped an empty package tray 420 (step723), the control system initiates a retract stack release signal atstep 724 so that the next accessible empty package tray is retained inthe stack by the stack release lever as the gripper is retracted androtated to a horizontal position for package loading.

While the stack release lever is retracting (step 725), the system willperform a check at step 726 to determine whether a time-out flag hasbeen generated by the control system indicating a time-out error. If atime-out flag has not been generated at step 726, then the release leverhas fully retracted (step 725). If the time-out flag is generated by thecontrol system as a time-out error, then the cycle jam procedure will beimplemented at step 775 shown in FIG. 4(b).

As indicated at step 727 in FIG. 4(b), the extended pneumatic packageload gripper arm 758 and vacuum gripper 759, that is now carrying anempty package tray 420, is caused to retract to a position to facilitateits rotation to a horizontal position (step 729). While the pneumaticpackage load gripper arm 758 is retracting, the system will perform acheck at step 727b to determine whether a time-out flag has beengenerated by the control system indicating a time-out error. If atime-out flag has not been generated, then the package load gripper armhas reached its fully retracted position (step 727a) while grasping anempty package tray 420. If the time-out flag is generated by the controlsystem as a time-out error, then the cycle jam procedure will beimplemented at step 775 shown in FIG. 4(b).

After the pneumatic package load gripper arm 758 carrying an emptypackage tray 420 has retracted while retaining an empty package tray, itmust be rotated to an oriented position to enable placement of thepackage tray on the guide pins 544 extending from the support surface542 of the plate 540 of the tool nest 516. As shown at step 728 in FIG.4(b), the vacuum gripper 759 gripping empty package tray 420 is rotatedto a horizontally oriented position to aid in the positioning of theempty package tray 420 onto the nest plate 540. While the rotaryactuator enables pneumatic package load gripper arm to rotate the emptypackage tray 420 to a fully horizontal position, the 5 system willperform a check at step 728a to determine whether a time-out flag hasbeen generated by the control system indicating a time-out error. If atime-out flag has not been generated, then the package load arm hasfully rotated (step 728a). If the time-out flag is generated by thecontrol system as a time-out error, then the cycle jam procedure will beimplemented at step 775 shown in FIG. 4(b).

As shown in the pneumatic schematic diagram of FIG. 50(c), supply line701a supplies filtered, monitored, and pressurized air to the rotaryactuator 760 which rotates the package tray 420. The clockwise andcounterclockwise operation of the rotary actuator 760, is controlled bycontrol lines 704c,d which operate the switch 707m under the timing andcontrol of the control system 99.

The next step of the package load process 710, is to transfer the emptypackage tray 420 from the vacuum gripper 759 onto the guide pins 544 ofplate 540 of package tool nest 516. To accomplish this, the package loadgripper arm 758 is again extended and the vacuum mode is switched, i.e.,turned off, at step 730 to accomplish the transfer. While the pneumaticpackage load gripper arm 758 is extending and the vacuum mode isswitched off to enable the transfer of the empty package, the systemwill perform a check at step 732 to determine whether a time-out flaghas been generated by the control system indicating a time-out error. Ifa time-out flag has not been generated, then the vacuum mode has beenswitched (step 731). If the time-out flag is generated by the controlsystem as a time-out error, then the cycle jam procedure will beimplemented at step 775 shown in FIG. 4(b).

After the transfer of the empty package onto the package tray 420 hasbeen completed, the package load gripper arm 758 is retracted from itsextended position at the tool nest 516 as shown at step 733 in FIG.4(b). While the pneumatic package load gripper arm 758 is retractingfrom its position at the tool nest after transferring an empty tray 420,the system will perform a check at step 735 to determine whether atime-out flag has been generated by the control system indicating atime-out error. If a time-out flag has not been generated, a check ismade again to determine if the arm has been fully retracted (step 734).If the time-out flag is generated by the control system as a time-outerror, then the cycle jam procedure will be implemented at step 775shown in FIG. 4(b).

The last step of the package load process 710, is to rotate the packageload gripper arm 758 back to its initial vertical position for enablingthe vacuum gripper 759 to pick up the next empty tray 420 from the stackof empty packages. To accomplish this vertical rotation, the rotaryactuator 760 is enabled to rotate as indicated at step 736 in FIG. 4(b).While the rotary actuator enables pneumatic package load gripper arm 758to rotate to its initial vertical position, the system will perform acheck at step 738 to determine whether a time-out flag has beengenerated by the control system indicating a time-out error. If atime-out flag has not been generated, a check is made again to determineif the package load arm has fully rotated (step 739). If the time-outflag is generated by the control system as a time-out error, then thecycle jam procedure will be implemented at step 775 shown in FIG. 4(b).

The final step of the package load process 710 is to update the counterthat keeps track of the number of empty packages in the package supplystack. This is indicated as step 740 in FIG. 4(b).

(2) The second of the successive workstations located about the rotarysuture wind and package dial 500, is the package detection station 450shown in FIG. 4(a) as step 750. The package or tray 420 detectingworkstation 450, as shown in FIGS. 29 and 30, which may be optional onthe machine, includes a suitable sensor 551 which is mounted on the armof a stationary bracket arrangement 552 to provide assurance that a tray420 has actually been physically positioned on the support surface orplatform 542, and retained thereon by means of the guide pins 544projecting radially outwardly through the apertures in the tray 420.Specifically, sensor 551 is interfaced with and adapted to provide thisinformation to the control system 99 for the packaging machine as to therequired presence of a tray 420 in order to enable subsequent packagingsteps to be implemented by the packaging machine responsive thereto.

The control process 750 for package tray 420 detection at station 450 isillustrated in FIG. 4(c). The only step indicated as step 749 in FIG.4(c), is to verify by the sensor 550 that the package tray 420 ispresent. If it is not present, then the cycle jam procedure will beimplemented at step 775 shown in FIG. 4(c).

Needle-Suture Load to Package Station

(3) The third workstation indexed in the direction of arrow "A" shown inFIG. 25 involves the multi-axis gripper 155 of the rotary swage dial 150for inserting a specified number of surgical needles and attachedsutures into the suture tray 420 indexed by the packaging dial 500 in aconfrontingly opposed relation to the multi-axis gripper. The needlesare fed by the multi-axis gripper 155 so as to be positioned on asuitable clamping structure formed integrally with the central surfaceportion of the suture tray 420, as shown in FIG. 46 of the drawings andexplained in detail in copending patent application Ser. No. 08/181,626(attorney docket No. 8925) assigned to the same assignee of the presentinvention and incorporated by reference herein.

Generally, to load the first armed needle into the empty package 420,the tool nest 516 is brought to station 600 in its home position asshown in FIG. 31. Simultaneous therewith, the multi-axis gripper 155 isindexed from the pull-test station 300 to station 600 where it is thenextended toward the empty package 420, as described above with respectto step 14 of FIG. 3(a), to deposit the needle 9 within a pair 418 ofneedle receiving notches or clamping grooves 416 formed betweenintegrally molded protruding fences 419 in the face 426 of the tray 420.Specifically, after the multi-axis gripper 155 has been extended towardthe tray in the manner described above, the control system 99 actuatessolenoid 455 to enable push rod 460 to depress the plunger 149 on themulti-axis gripper so that it may release its grip of the armed needle 9and park the needle onto the package. This constitutes needle handoff asindicated at step 25 in FIG. 3(a). After depositing each needle, thepins of the multi-axis gripper are returned to their gripping (butempty) position as indicated at step 31(c) in FIG. 3(a) for subsequentindexing to the next workstation, where a new needle will be picked upfor swaging.

As shown in FIG. 32(a), each paired set of notches 418 are consecutivelynumbered and lie approximately 0.25 inches apart. The first needle ispreferably loaded at the eighth or "home" position as shown in FIG.32(a), but it can be just as easily loaded in the first positionlabelled "1". As illustrated in FIGS. 31 and 32(a) through 32(c), thetool nest 516 assembly and, consequently, the empty tray 420 is slightlytilted from the vertical with respect to the orientation of themulti-axis gripper 155 so that the curved needle will be accuratelydeposited within the paired notches formed in the package. This tilt,which may be about 10°-20° from the vertical, and about 16° from thevertical, may be effected due to the contact between the cam rollers 530and an angled or sloped camming surface on cam dial plate 533 atworkstation (3), as shown in FIG. 26. As a result of this tiltingoffset, the needles are slightly shifted relative to each other, and thesutures depending downwardly therefrom will not tend to tangle with eachother.

As shown in FIGS. 31, 32(a) through 32(c), and 33(a) and 33(b), there islocated at the workstation 600 a package elevator assembly 430 thatregisters the empty tray 420 to receive eight individual armed needles,one at a time.

As illustrated in drawings, the tool nest 516 includes the fixed bodystructure 520 containing the rotatable shaft 528 at which there ismounted the package tray holding platform or support surface 542 and thepreviously-described structure. Most of the turret stations, which asshown in FIG. 25 of the drawings are in this case eight (8) in number,require that the tool nest 516 is precisely maintained in a non-rotatedvertical position, as illustrated specifically in FIGS. 26 and 28(a).This particular vertical orientation is maintained in that the circularstationary cam dial plate 533 extending between the collectiveworkstations is contacted by the two cam followers 530, which are in theform of cam rollers 530a and 530b mounted on shaft 528 so as to straddlethe longitudinal centerline of the latter, for each of the tool nestsmounted on dial 514.

Prior to needle insertion at the needle inserting workstation, the tray420 is adapted to be rotated into a tilted orientation throughpreferably an angle of 16° counter-clockwise so that needles are to bepositioned in a correct array and orientation in the needle parkstructure of the tray. This is attained by a tool nest rotatingstructure, as illustrated in drawing FIGS. 33(a) and 33(b), operating infunctional sequence essentially as follows:

FIG. 33(a) is an elevational view of the needle-suture load to packagestation 600 showing the indexing turret 514 upon which the tool nest 516has been mounted, consisting of the tray holding plate 540, includingthe tray supporting surface or platform 542. The shaft 528 is mounted insuitable bearings, (i.e. 529a and 529b) so as to be freely rotatablewithin the housing 520 of the tool nest 516, if required to do so.

As a specific tool nest 516 which has the tray mounted thereon at thefirst workstation, and which is adapted to be supplied with the needles,enters the needle and suture load to package workstation, in thedirection of arrow A, the tool nest 516 enters the tilt mechanism 535.The two cam followers 530, hereinafter designated as cam rollers 530aand 530b, roll along the upper surface of the stationary cam dial plate533, as illustrated by phantom lines at the left-hand side, and thenpass into the index mechanism 535 stopping in the position shown insolid lines in FIG. 33(b).

A track section 541 which consists of an insert having upper surface 543normally in coplanar relationship with the upper surface of the cam dialplate 533, and which extends through a cutout 545 formed in the cam dialplate 533, has its uppermost position determined by shoulders 543a and543b bearingly contacting against mating lower surfaces 545a and 545b onthe lower side of the stationary cam dial plate 533. Normally, the tracksection 541 is biased upwardly into the cutout 545 under the urging ofcompression springs 547 which are supported against a suitable springsupport member 549. At this position, the upper surface 543 of theinsert 541 is in the same plane as the upper surface of the cam dialplate 533.

A displacement cam element 551 is in a normally raised position abovethe cam rollers 530a, 530b to enable the latter to roll into the indexmechanism 535 workstation and enabling the tilting mechanism to operatewithout any interference of components in the rest or dwelling position,as illustrated.

In order to rotate or tilt the tool nest 516 for appropriate needleinsertion, an air cylinder 553 of the mechanism 551, which is attachedby means of suitable screws 555 to a plate structure 557 mounted abovethe camming dial plate 533; through a cylinder rod 559a of a pistondevice 559 causes the downward displacement of the cam element 551. Thisdownward motion is guided by a suitable sliding device (not shown). Thelower cam surface 551a of the displacement cam element 551 exerts adownward force against cam roller 530b which, in turn, forces the insert541 to move downwardly within the cutout 545 provided in the cam dialplate 533, compressing the springs 547, and thereby rotating the shaft528 in the housing 520 of the tool nest 516 counter-clockwise about axis528a. The downward movement continues until the upper surface portion551b of the displacement cam element 551 contacts the other cam roller530a which has been displaced upwardly an amount equal to the downwarddisplacement of cam roller 530b, and the system reaches the end oftravel, causing the air cylinder to maintain the position, as shown inFIG. 33(a). The foregoing results in a rotational movement of shaft 528to which the cam rollers 530a and 530b are fastened, and resultingly ofthe support surface 542 and tray mounted at the opposite other end ofthe shaft 528 in a counterclockwise direction, preferably to a tiltingangle of 16°.

After completion of the needle insertion operation, this sequence isreversed in that the air cylinder receives compressed air so as to raisethe displacement cam element 551. As a consequence, the springs 547cause the insert 541 to be biased upwardly, causing the upper surface543 thereof to press against the cam roller 530b and causing shaft 528to rotate clockwise. This continues until the shoulders 543a,543bcontact the stationary surfaces 545a, 545b at the lower side of the camdial plate 533, thereby stopping this rotational motion. This clockwiserotation of the shaft 528 causes the cam roller 530a to move a lowerposition until it contacts the upper surface 543 of the insert 541 whichis now located in the same plane as the upper surface of the stationarycam dial plate 533. A suitable switch, for example, a proximity switch(not shown) now indicates that all of the mechanical components of thisarrangement have been returned to the original position of FIG. 33(a),and the dial 514 indexes the tool nest forward for the next operatingcycle. FIG. 33(b) shows a dashed line representation of the cam rollers530a and 530b rolling on the surface of the tool cam dial plate 533towards the right, and the shaft 528 being displaced from thisworkstation.

This aspect provides a structure of providing a rotary tiltedpositioning of a product on an indexing turret, in this applicationrotation of the shaft 528 and tilting the package or tray mountedthereon by means of the support plate 536 and platform 542, such asthrough an angle within the range of 10° to 30°, and preferably about16°, due to the parallel offset distance between the camming surfaces551a, 551b on the displacement cam element 551 which contact the camrollers 530a and 530b.

In FIG. 33(c) there is disclosed schematically an alternative design,similar to the foregoing, however, in which the individual structuralcomponents of the tilting arrangement are combined into an integralmodular unit.

A shaft 446 of elevator assembly 430, as shown in FIG. 32(a), raises theplate 540 essentially vertically but slightly skewed (at about 16°) in0.25 inch increments to sequentially receive eight needles from themulti-axis gripper 155 as described above. In this embodiment, therotation of the swage dial 150 supplying armed needles from thepull-test station 300 at a rate of approximately 60/min. is synchronizedwith the vertical incrementing of the plate 540 mounting the tray 420 tomaximize production rates. For example, after inserting the first armedneedle 9 into the empty tray 420 into the paired notches numbered "8" asdescribed above, the elevator shaft 446 raises the plate 540 verticallyfor 0.25 inches so that the next armed needle 9 may be deposited in thepair of notches 418 numbered "7." Simultaneous with the registering ofthe tool nest plate 540, the rotary swage dial 150 indexes the nextmulti-axis gripper 155 carrying the second armed needle, so that it mayinsert the next needle in the second position (notch "7") of the tray420. This process takes place eight (8) times to fill a reduced sizeorganizer package containing eight (8) armed surgical needles. After theeighth needle has been inserted in the package, the elevator assembly430 retracts the elevator shaft 446 by conventional means such as apneumatic air cylinder (not shown). Thus, the tray 420 which is nowequipped with eight armed needles is in its initial position on the toolnest 516 and the tray is ready for further treatment at successiveworkstations.

In the preferred embodiment, the rotation of the swage dial 150supplying armed needles from the pull-test station at a rate ofapproximately 60/min. is synchronized with the vertical incrementing ofthe package nest carriage to maximize production rates. As shown in FIG.4(a) the process 760 of indexing the empty package tray 420 to receivean armed needle takes place eight (8) times until the package tray 420has been fully loaded.

As illustrated in FIG. 4(d) the process 760 of loading armed needles tothe empty package tray 420 begins with the step 761 of determiningwhether the NEEDLE REJECT bit had been set as a result of the needle-suture assembly failing the minimum pull-test at steps 65b (FIG. 3(e))or 76a (FIG. 3(f)) described above. If the needle was rejected byfailure of the pull-test, the process 760 ends. Otherwise, theneedle-suture will be inserted into the package.

At step 762, the motor that controls the elevator assembly 430 thatraises elevator shaft 445 is indexed to the next needle insert positionif it is not the first needle being indexed. The status of the suturewind and package dial drive motor (not shown) is continuously monitored,as indicated at step 762a in FIG. 4(d), to ensure that the package tray420 is properly indexed at the needle-suture load to package station600. Until the motor is done, the system will perform a check at step763 to determine whether a time-out flag has been generated by thecontrol system indicating a time-out error. If a time-out flag has notbeen generated, the monitoring continues (step 762a). If the time-outflag is generated by the control system as a time-out error, the processwill be terminated and prompted for reinitialization at step 959. Oncethe motor has properly indexed the empty package tray 420 with themulti-axis gripper, a counter (not shown) is incremented at step 765 tokeep track of the amount of needles loaded into the respective packagetray 420. For example, after inserting the first armed needle into thefirst set of paired notches 416 numbered "8," the plate 540 is raisedvertically by elevator shaft 445 of elevator assembly 430 so that thenext armed needle 9 may be deposited in the pair of notches 416 numbered"7". Simultaneous with the registering of the plate 540, the rotaryswage dial 150 rotates to index the next multi-axis gripper 155 carryingthe second armed needle, so that it may be inserted in the secondposition (notch "7") of the package 420. Each time this process takesplace as indicated at step 765 the counter is incremented until theeighth count is reached. Then, when the eighth count is reached, asignal is generated by the control system 99 to enable the plate 540 andplatform 542 to return to its home position on the suture wind andpackage dial 500 as indicated at step 768 of FIG. 4(d). A continuouscheck is made at step 767 in FIG. 4(d) to determine whether the packagetray 420 has been returned to the home position. Until the package tray420 has been indexed back to its home position, the system will performa check at step 769 to determine whether a time-out flag has beengenerated by the control system indicating a time-out error. If atime-out flag has not been generated, the monitoring continues (step767). If the time-out flag is generated by the control system as atime-out error, the process will be terminated and prompted forreinitialization at step 959. When the package tray 420 carrying theeight armed needles is in its home position, it is ready for furtherpackaging at the subsequent stations along the suture winding andpackaging dial 500. As indicated at step 967 in FIG. 4(a), a set DONEbit is generated for use by the control system computer 99.

In an alternative embodiment, the needle-suture assemblies may first beparked in the package tray notch labelled "1" with the elevator assembly430 in its most raised position. Contrary to the operation describedabove, the elevator assembly may be subsequently decremented in equalsteps with the needles successively inserted in locations "2"-"8" i.e.,with the last (eighth) needle-suture assembly being parked in the eighthposition in the tray 420 and the package tray and tool nest in its homeposition.

A suture check may also be performed at the needle-suture load topackage station 600. One way of implementing this suture check would beto situate a suitable LED and phototransistor (or photodiode)combination in the travel path of the needle-suture assembly. If asuture portion of the needle-suture assembly is present, then the suturewill break the light beam of the LED combination which would indicatethat a suture is present. If the light beam of the LED combination isnot broken in the machine cycle, this would indicate that a suture isnot attached to the needle, and the package will be flagged as beingdefective. Note that this suture check may be performed at the swagingstation after a needle is swaged or even after minimum pull-testing.

(4) Although not indicated in FIG. 4(a) an optional needle detectorworkstation 475 may be provided for verification of the presence andproper positioning of the needles and sutures having been introducedinto the tray 420 by the multi-axis gripper 155, as illustrated inFIG. 1. As shown in FIG. 34, needle detector unit 560 consisting of astationary bracket unit is adapted to be positioned opposite theplatform 542 indexed in front thereof and mounting the needlefilled tray420, and then advanced axially towards the latter to enable a pluralityof sensors 562 mounted on a housing 564 movable thereon and interfacedwith control system 99 to ascertain that the appropriate number ofsurgical needles have been properly introduced into and parked in properarray in the tray 420 by the multi-axis gripper 155 at the precedingworkstation 600. Upon the needle sensors 562 verifying to the controlsystem 99 the presence of the required quantity and parking of thesurgical needles in the tray 420, the sensors 562 and housing 564 areretracted away from the tray 420 on platform 542 to enable the suturewind and packaging dial 500 to index the tool nest 516 forwardly to afurther workstation.

The control process 770 for needle detection at station 475 isillustrated in FIG. 4(e). The first step indicated as step 771 in FIG.4(e), is to extend the needle detector unit 560. A continuous check ismade at step 772 in FIG. 4(e) to determine whether the needle detectorunit 560 has been extended. Until the needle detector unit has beenfully extended, the system will perform a check at step 773 to determinewhether a time-out flag has been generated by the control systemindicating a time-out error. If a time-out flag has not been generated,the check is made again to determine if the needle detector unit hasbeen fully extended (step 772). If the time-out flag is generated by thecontrol system as a time-out error, then the cycle jam procedure will beimplemented at step 775 shown in FIG. 4(e).

Prior to step 771, an optional step 771a may include extending acylinder or suitable steadying device (not shown) to aid in holding thepackage steady as the needle detect mechanism checks the presence ofneedles in the package tray.

Next, at step 776 a determination is made whether all eight (8) needlesare present within the package tray 420. If not, a set PACKAGE REJECTbit is generated at step 777 for subsequent use by the control system 99to initiate a rejection of the completed package at the cover loadstation 650. If, all eight (8) needles are present, then the controlsystem initiates the retraction of the needle detector unit 560 at step778. It should be understood that this station is optional and couldvery well be placed downstream of the suture winding station 550 forneedle detection after the sutures have been wound around the tray.

(5) A suture winding workstation 550, to which the tray 420 is adaptedbe indexed, comprises a suture winding apparatus 570, by means of whichsutures depending from the needles outwardly of and hanging downwardlyfrom the tray 420 are wound into the confines of the tray 420, andparticularly the peripheral channel as illustrated in FIG. 46, and asshown in FIGS. 35(a), 35(b), 35(c) and 36 of the drawings. Thedownwardly loosely hanging sutures extending from each of the needles,as described hereinbelow, are positionable so as to be tensioned in astationary vacuum device or unit 572 located below the tool nest 516supporting the suture tray 420 at this workstation, and to thereby causethe sutures to be tensioned and bundled into a compact strand, theoperational sequence of which is illustrated in and described in moreextensive detail hereinbelow with regard to FIGS. 35(a) through 35(c) ofthe drawings directed to the operational aspects of winding apparatus570.

The cam plate member 536 of the tool nest mounting the needle andsuture-filled tray 420 on platform 542 at this workstation is adapted tobe contacted along the cam surface 538 thereof by cam followercomponents 574 located on a stylus arrangement 576 of apparatus 570,which is employed for guiding and winding the sutures into theperipheral channel of the tray 420. The stylus arrangement 576 includesa stationary cylinder 578 having a pneumatically-actuatable centralpiston 580 longitudinally reciprocable therein for movement towards andaway from the tray 420. The cam follower components 574 comprisearticulatingly connected rollers 574a and 574bcontacting the peripheralcam surface 538 of the cam plate member 536, the latter of which, inconjunction with the support plate 540 mounting the tray 420, is rotatedby the computer-controlled rotation of shaft 528 about a horizontalcentral axis 528a extending normal to the plane of the plates 536, 540and the tray 420 so as to facilitate winding of the sutures into theperipheral channel of the tray 420, as shown and elucidated with regardto the description of operation of FIGS. 35(a) through 35(c ) and 36.

Referring more specifically to the construction of the tray 420 shown inFIG. 46 of the drawings, which as indicated hereinabove is essentiallythe needle and suture-containing tray 420 constituting, in combinationwith an attached cover, the components of the multi-strand suturepackage of the above-mentioned U.S. Pat. No. 5,230,424. Referring to thebasic constructional features thereof, the tray 420 has a planar base580 of generally rectangular configuration extending into roundedcorners 582. Extending about the periphery of the base 580 is anupstanding wall 584, and spaced inwardly thereof in parallelrelationship is a further upstanding wall 586 so as to form a peripheralchannel structure 588 therebetween. Extending over the channel 588outwardly from the inner wall 586 are a plurality of contiguouslyarranged essentially resilient retaining fingers 590, which arecantilevered so as to extend most of the way over the channel 588 fromthe upper edge of the inner wall thereof for preventing sutures fromlifting up out of the channel. A gap 592 formed in the array of theretaining fingers 590 along the length of the channel, preferablyproximate the juncture or corner between two of the rectangular sides ofthe tray 420 permits the end of each of the sutures to emerge from thechannel 588, as shown in FIG. 46 of the drawings.

The central region of the base 580 of the tray 420 within the inner wall586 includes integral structure which provides a plurality ofspaced-apart gaps enabling the clamping therein of the suture needles soas to "park" the latter in the tray 420, as is clearly shown in thedrawing and described in detail above, and with each of the needleshaving one end of a respectively associated suture attached or swagedthereto.

The functioning of the components of the stylus arrangement 576 forwinding the suture into the tray 420 is described in more extensivedetail in connection with FIGS. 35(a) through 35(c) of the drawings,illustrating more specifically the vacuum unit 572, a pivotable leverwhich is operable in conjunction therewith for tightening and tensioningthe suture bundle, and the stylus arrangement 576 cooperating with theresilient fingers 590 of the tray 420 in order to feed the sutures intothe channel in a winding motion as the tray 420 is being rotated by itssupporting platform 542 due to rotation of shaft 528 about axis 528a.

Adjacent the winding station and extending over the stylus arrangement576 as shown in FIGS. 37 and 38 of the drawings, there is arranged atray restraint device 601 which comprises L-shaped brackets 602 havingupright legs 604 thereof fastened to a stationary surface, and topportions 606 extending horizontally over the rotary dial 514 and thedial cam plate 533 thereon, and being operatively connected through asuitable drive arrangement 608 with an inner end of the shaft 528extending through the housing 520 and which is connected with the camplate 536 and plate 540 mounting the suture tray. A shaft 610 extendsthrough legs 604 of the stationary bracket 602 and upon initiation ofthe suture winding operation, is displaced axially towards the tray 420,either pneumatically or electrically by control means 99 such that arestraint plate 612 contacting the outwardly facing tray 420 surfacecomes into operative engagement with at least a center portion thereofso as to inhibit the tray 420 from being expelled outwardly from itsmounted position on the platform 542 during the suture winding sequence,and, to prevent the sutures from being pulled out from their associatedneedles by the tension imparted to the bundled suture strands. Theinterengagement of the restraint plate 612 and the tray 420, and therotation imparted to the shaft 528, will cause the shaft 610 in the legmember 604 of the bracket 602 of the restraint arrangement to rotate inconjunction with the rotation of shaft 528. Upon completion of thewinding procedures, the control system 99 will cause the restraint plate612 to be shifted away from the tray 420 into an inoperative position,so as to enable the tray 420 on its tool nest 516 to be indexed to afurther workstation by the advance of the rotary dial 514 in thedirection of arrow A of FIG. 38.

As shown in FIG. 35(a), the rotary dial 514 has just indexed to thesuture winding workstation with a tray 420 attached to its platform 542.In this position, the bundle of sutures, in this instance, eight sutureseach respectively attached to one of the surgical needles parked in thetray, hang downwardly from the tray and enter the vacuum gatheringdevice 572 which has an internal V-section 573 wherein a generatedvacuum applies tension to the sutures and collects and stretches theminto a bundled strand. The vacuum is created by a vacuum being pulledfrom an exhaust port 573a which creates an airflow into the "V" shapethrough suitable vent holes 573b. Concurrently, as shown in FIGS. 35(a)through 35(c), the entire tray supporting platform 542 and cam platemember 536 are subjected to rotation about axis 528a in the direction ofarrow B responsive to the operation of shaft 528 by means of aprogrammable servomotor 613, as illustrated schematically in FIGS. 37and 38.

As shown in FIG. 35(a), the turret index which has moved the tray to thesuture winding station is complete, and this motion has dwelled inpreparation for the winding function for the sutures.

The suture winding workstation as illustrated in FIG. 25 of the turret500 includes structure for rotating the package and to accomplish thesuture winding operation. This is accomplished by a motorized drivingmechanism as shown in FIGS. 39(a) through 39(c) and 37. The primaryrotary dial 514 as shown in FIG. 37 which has the tool nest 516 thereoncontaining shaft 528 mounted in suitable bearings 529a, 529b in housing520.

As the winding machine is indexed for a next suture winding cycle, thetool nest 516 is moved into the rotational station 680 as shown in FIG.39(a), indicated by arrow C. The cam rollers 530a and 530b cross a gap682 provided in the stationary cam dial plate 533 and enter a slot 684formed by opposite parallel surfaces 686, 688 formed in a driven roller690, the latter of which extends partly into the gap 682 produced by acutout provided in the cam dial plate 533. The lower surface 688 of slot684 is normally substantially in coplanar and axial alignment with theupper surface of the cam dial plate 533 enabling the rollers 530a and530b to be centered therein. This centering action takes place in adwell position of the dial 514 in the suture winding workstation,whereby the longitudinal centerline 528a of shaft 528 is coincident withthe centerline of the driven roller 690. The drive roller 690 is mountedin suitable bearings such as to be able to be rotated by the servomotor613 driving a timing belt 692 extending from a driving roller 694 to thedriven roller 690 so as to operatively interconnect the rollers 690,694.

When the winding cycle is started at the suture winding station, asshown in FIG. 35(a), the servomotor 613 drives the driving roller 694which, in turn, drives the driven roller 690 through the timing belt692. At the end of the winding operation, the driven roller 690 isstopped to cause a horizontal orientation to be assumed by the slot 684and the opposite surfaces of the slot are coplanar or coextensive withthe upper surface of the cam dial plate 533. The dial 514 then indexesin the direction of arrow D, advancing the cam rollers 530a and 530b outof the slot 684 of the driven roller 690 and onto the upper surface ofthe tool camming plate 533, thereby locking the support plate and trayinto a vertical tray orientation which is secured against rotation. Asuitable switch, such as a proximity switch (not shown) assures that thedriven roller 690 is in the horizontal slot orientation before indexingthe dial 514 forwardly, thereby preventing any mechanical interferencebetween components which could damage the latter. The rollers 690 and694 may be suitable sprocket wheels, and the timing belt 692 a sprocketbelt or chain.

The programmable servomotor 613 which rotates shaft 528 having the toolnest 516 fastened thereto and, effectively, the support platform 542 andcam plate 536 for the tray 420 about its center rotational axis 528ahascompleted an initial counter-clockwise rotation in the direction ofarrow B, causing the suture bundle to wrap around a pin 575 whichprotrudes from the suture tray towards the viewer, when looking into theplane of the drawing. This rotation pulls the suture bundle partiallyout of the vacuum gathering device 572, which imparts a predeterminedtension to the suture bundle causing it to become straight and theindividual strands or sutures to be collected into a parallel andtightly confined group. The winding stylus assembly 576 which is mountedon a stationary plate is shown in its retracted position in cylinder578, as it is during turret index.

In FIG. 35(b), the subsequent phase of the winding operation isillustrated wherein a suture positioning arm 577 has been actuated torotate clockwise, bringing a roller 577a to bear against the suturebundle, thereby implementing two functions:

(a) The suture bundle length is increased between the pin 575 and thevacuum device 572 causing additional suture length to be drawn out ofthe vacuum device and resulting in a tighter more confined suturebundle.

(b) Moreover, the foregoing displaces the suture bundle towards theright, so that a winding stylus 579 having fingers or legs 579a and 579bcan straddle the bundle in the now extended position of the stylusarrangement, and be dropped on the floor of the tray channel 588 (in amotion perpendicular to the plane of view into the drawing) with areasonable assurance that the bundle strands will not become pinched orfall outside of the stylus legs 579a, 579b.

FIG. 35(b) also illustrates the winding stylus assembly 576 extendedtowards the tray 420 by the extension of the air cylinder 581 until thestylus guide rollers 574a, 574b contact the peripheral cam surface 538of the tool nest. The air cylinder 581 maintains a force against therollers 574a, 574b during rotation of the tray 420 for winding, actingin a manner of a spring as the rollers force the stylus head 579 and theslide 583 to oscillate. The slide oscillates within the stationary slideholder 585.

FIG. 35(c) illustrates the commencement of the tray rotation on thesupport surface 542 for effectuating winding of the sutures. The aircylinder exerts a constant force on the slide 583, and through a pivotpin 587 to the roller assembly 574a, 574b. The stylus 579, which ismounted in the roller assembly is maintained at 90° relative to thesuture track by this action. The enlarged encircled detail view of FIG.36 discloses the suture bundle after it is positioned below theresilient suture-retaining tray fingers 590. This also illustrates themanner in which the stylus 579 plows under the tray fingers, raising andlowering them progressively as it leads the suture bundle therebeneathand guides the bundle into the peripheral channel 588 of the tray 420.As this winding takes place, the vacuum device 572 maintains a constantessentially gentle tension on the suture bundle as it is withdrawntherefrom, and this action continues until the suture bundle endswithdrawn from the vacuum device are fully inserted by the stylus 579under the resilient tray fingers 590 into the peripheral suture traychannel 588. At this final point of the winding cycle, the tool nest 516mounting the tray is rotated to position the stylus in the suturechannel window or gap 592, as shown in FIG. 46, whereupon the stylus 579is raised upwardly out of the tray and the air cylinder retracts thestylus assembly, i.e. the piston rod mounting the latter, to theposition shown in FIG. 35(a). Rotation of the tool nest mounting thetray with the needles parked therein and the sutures wound into thechannel 588 continues in a counter-clockwise direction until the needlepark is vertical with the needle points extending downwardly. The rotarydisc 514 is then indexed for the next cycle, in effect, for receivingand winding a subsequent tray.

During the foregoing suture winding sequence of operation, as previouslymentioned, the restraint device 601 continually maintains its contactwith the tray so as to prevent the tray and the contents therein frombeing expelled from the support platform 542 on which the tray 420 ismounted, and also to prevent the sutures from being pulled out from theneedles. The restraint device 601 is withdrawn from the tray 420 uponcompletion of the suture-winding procedure to enable the continuedforward indexing rotation of rotary turret 510. Additionally, drivemember 530a and cam followers 530 located therein are returned to ahorizontal position so the cam followers can leave the slot 684 andre-enter on top of cam plate 533 without mechanical interference as dial510 indexes for the next cycle.

The control process 800 for the package wind station 550 is illustratedin FIG. 4(f). The first step, indicated as step 801 in FIG. 4(f), is thecommand to rotate the positioning arm (cylinder 578) of the windingapparatus 570 to position the stylus arrangement 576 proximate the toolnest and the dwelled suture package carrying the needle sutureassemblies. A continuous check is made at step 801a in FIG. 4(f) todetermine whether the stylus arm has rotated to the suture windingposition. Until the positioning arm has fully rotated, the system willperform a check at step 801b to determine whether a time-out flag hasbeen generated by the control system 99 indicating a time-out error. Ifthe time-out flag is generated by the control system as a time-outerror, the process will be terminated and prompted for reinitializationat step 959 in FIG. 4(f).

The next step, indicated as step 803, is to extend the suture restraintdevice 601 and supply the vacuum to the vacuum unit 572 for gatheringand tensioning the suture bundle. A continuous check is made at step802a in FIG. 4(f) to determine whether the suture restraint device 601has been extended. Until the restraint device has been fully extended,the system will perform a check at step 803 to determine whether atime-out flag has been generated by the control system 99 indicating atime-out error. If a time-out flag has not been generated, the check ismade again to determine if the suture restraint device has been fullyextended (step 802a). If the time-out flag is generated by the controlsystem as a time-out error, the process will be terminated and promptedfor reinitialization at step 959 in FIG. 4(f).

As shown in the pneumatic schematic diagram of FIG. 50(c), supply line701a supplies filtered, monitored, and pressurized air to the suturerestraint plate 612 which engage the rotating tray 420 and prevents itfrom being expelled while in suture winding rotation. The retractableoperation of the suture restraint plate 612, is controlled by controllines 704c,d which operate the switch 707n under the timing and controlof the control system 99.

The next step of the suture wind process is to extend the stylusarrangement 576 from its retracted position within cylinder 578 ofsuture winding apparatus 570, prior to winding the bundled sutures inthe suture receiving channel of the tray 420, as indicated at step 805in FIG. 4(f). A continuous check is made at step 806 in FIG. 4(f) todetermine whether the stylus has been extended. Until the winding stylus576 has been fully extended, the system will perform a check at step 807to determine whether a time-out flag has been generated by the controlsystem 99 indicating a time-out error. If a time-out flag has not beengenerated, the check is made again to determine if the stylus unit hasbeen fully lifted (step 806). If the time-out flag is generated by thecontrol system as a time-out error, the process will be terminated andprompted for reinitialization at step 959 in FIG. 4(f).

As shown in the pneumatic schematic diagram of FIG. 50(c), supply line701a supplies pressurized air 5 through suitable filter 702 and pressuremonitoring device 703c to the stylus slide arrangement 576 thatmanipulates the resilient fingers 590 as the tray 420 rotates to enablethe suture bundle to wrap around the channel. The retractable operationof the stylus arrangement 576, is controlled by control lines 704c,dwhich operate the switch 707p under the timing and control of thecontrol system 99.

The next step of the suture wind process is to extend the pivotablelever 577 for tightening and tensioning the suture bundle prior towinding thereof as indicated at step 811 in FIG. 4(f). A continuouscheck is made at step 812 in FIG. 4(f) to determine whether the leverhas been extended. Until the pivotable lever has been fully extended,the system will perform a check at step 813 to determine whether atime-out flag has been generated by the control system 99 indicating atime-out error. If a time-out flag has not been generated, the check ismade again to determine if the lever has been fully extended (step 812).If the time-out flag is generated by the control system as a time-outerror, the process will be terminated and prompted for reinitializationat step 959 in FIG. 4(f).

After the suture bundle has been gathered and tensioned by cooperationof the pivotable lever 577 and vacuum unit 572, the motor 614 thatdrives the platform 540 rotates the package tray 420 from its verticalposition for approximately 114° degrees to further tension the suturebundle and to position the bundled sutures within the gap 592 of thepackage tray to facilitate winding as indicated at step 815 in FIG.4(f). In the preferred embodiment, the motor 614 will rotate the packagetray 420 anywhere from 90° degrees to 114° as programmed in the controlsystem. A continuous check is made at step 816 in FIG. 4(f) to determinewhether the motor has rotated the package tray 420 for the appropriateangle necessary to further tension the suture strand bundle. Until themotor has been rotated, the system will perform a check at step 817 todetermine whether a time-out flag has been generated by the controlsystem 99 indicating a time-out error. If a time-out flag has not beengenerated, the check is made again to determine if the motor hasfinished rotating the platform (step 816) for 114° degrees. If thetimeout flag is generated by the control system as a timeout error, theprocess will be terminated and prompted for reinitialization at step 959in FIG. 4(f).

The next step of the suture wind process is to position the windingstylus 579 having legs 579a,b to straddle the suture bundle under thefirst resilient finger and within the suture receiving channel of thepackage tray 420 prior to winding thereof, and, to cause the stylusguide rollers 574a,b to contact the peripheral cam surface 538 of thetool nest in preparation for winding, as indicated at step 818 in FIG.4(g). A continuous check is made at step 820 in FIG. 4(g) to determinewhether the winding stylus has been so positioned as shown in FIG.35(b). Until the stylus 579 is brought to its straddling positioned, thesystem will perform a check at step 821 to determine whether a time-outflag has been generated by the control system 99 indicating a time-outerror. If a time-out flag has not been generated, the check is madeagain to determine if the winding stylus has been positioned (step 820).If the time-out flag is generated by the control system as a time-outerror, the process will be terminated and prompted for reinitializationat step 959 in FIG. 4(g).

As shown in the pneumatic schematic diagram of FIG. 50(c), supply line701a supplies pressurized air through suitable filter 702 and pressuremonitoring device 703c, to the stylus arm cylinder 580 that positionsthe suture bundle within the suture receiving channel. The retractableoperation of the stylus arm 581 822 is controlled by control lines704c,d which operate the switch 707q under the timing and control of thecontrol system 99.

After the winding stylus has been positioned to place the tensionedsuture bundle under one of the resilient fingers of the channel, themotor 613 for driving the platform 540 to rotate the package tray 420about its center rotational axis 528a, is enabled to wind the fulllength of the bundled sutures within the suture receiving channel of thepackage tray 420 as indicated at step 825 in FIG. 4(g). In the preferredembodiment, the motor will rotate the package tray 420 for threerevolutions (corresponding to a suture length of approximately 18inches), but, may be rotated for either two or four revolutionscommensurate with the length of the suture to be wound. A continuouscheck is made at step 828 in FIG. 4(g) to determine whether the motorhas rotated the package tray 420 for the appropriate amount ofrevolutions sufficient to secure the suture bundle within the channel ofthe package tray 420. Until the motor has been rotated, the system willperform a check at step 829 to determine whether a time-out flag hasbeen generated by the control system 99 indicating a time-out error. Ifa time-out flag has not been generated, the check is made again todetermine if the motor has finished rotating the platform (step 828). Ifthe time-out flag is generated by the control system as a time-outerror, the process will be terminated and prompted for reinitializationat step 959 in FIG. 4(g).

In the exact reverse to the procedure of positioning the stylus arm ofstep 818, the stylus arm is extended above the resilient fingers asindicated at step 831 in FIG. 4(g). A continuous check is made at step832 in FIG. 4(g) to determine whether the stylus 579 has been extended.Until the stylus has been fully extended, the system will perform acheck at step 834 to determine whether a time-out flag has beengenerated by the control system 99 indicating a time-out error. If atime-out flag has not been generated, the check is made again todetermine if the stylus unit has been fully extended (step 831). If thetime-out flag is generated by the control system as a time-out error,the process will be terminated and prompted for reinitialization at step959 in FIG. 4(g).

The next step of the suture wind process is to retract the pivotablelever 577 that had performed the suture tensioning function duringwinding operation as indicated at step 835 in FIG. 4(f). A continuouscheck is made at step 836 in FIG. 4(f) to determine whether the leverhas been retracted. Until the pivotable lever has been fully retracted,the system will perform a check at step 837 to determine whether atime-out flag has been generated by the control system 99 indicating atime-out error. If a time-out flag has not been generated, the check ismade again to determine if the lever has been fully retracted (step836). If the time-out flag is generated by the control system as atime-out error, the process will be terminated and prompted forreinitialization at step 959 in FIG. 4(f).

The next step is to fully retract the stylus slide back to its initialposition within the stylus cylinder 581 as indicated at step 841 in FIG.4(g). A continuous check is made at step 843 in FIG. 4(g) to determinewhether the stylus slide 578 has been retracted. Until the stylus slideunit has been retracted, the system will perform a check at step 844 todetermine whether a time-out flag has been generated by the controlsystem 99 indicating a time-out error. If a time-out flag has not beengenerated, the check is made again to determine if the stylus slide unithas been fully retracted (step 843). If the time-out flag is generatedby the control system as a time-out error, the process will beterminated and prompted for reinitialization at step 959 in FIG. 4(g).

After the stylus has been retracted to its initial position, the motor613 that drives the platform 542 to rotate the package tray 420, isenable to rotate the package tray 420 an additional 246° degrees toorient the package tray 420 back to its initial vertical positioningwith the surgical needle points extending downwardly as indicated atstep 845 in FIG. 4(h). In the preferred embodiment, the motor willrotate the package tray 420 for 246° degrees, or, for an angle up . to270° as programmed in the control system. A continuous check is made atstep 846 in FIG. 4(h) to determine whether the motor has rotated thepackage tray 420 for the appropriate angle necessary to correctly orientthe package tray 420. Until the motor has been rotated, the system willperform a check at step 847 to determine whether a time-out flag hasbeen generated by the control system 99 indicating a time-out error. Ifa time-out flag has not been generated, the check is made again todetermine if the motor has finished rotating the platform (step 846) for90 degrees. If the time-out flag is generated by the control system as atime-out error, the process will be terminated and prompted forreinitialization at step 959 in FIG. 4(h).

The next to last step, indicated as step 851 in FIG. 4(h), is thecommand to return the positioning arm 578 to its retracted position awayfrom the package and tool nest. A continuous check is made at step 852in FIG. 4(h) to determine whether the positioning arm has been rotated.Until the stylus arm 578 has been fully rotated, the system will performa check at step 853 to determine whether a time-out flag has beengenerated by the control system 99 indicating a time-out error. If atime-out flag has not been generated, the check is made again todetermine if the suture restraint device has been fully extended (step852). If the time-out flag is generated by the control system as atime-out error, the process will be terminated and prompted forreinitialization at step 759 in FIG. 4(h).

The last step of suture winding process 800, indicated as step 854 inFIG. 4(i), is the command to retract the suture restraint device. Acontinuous check is made at step 855 in FIG. 4(i) to determine whetherthe suture restraint device 601 has been retracted. Until the restraintdevice has been fully retracted, the system will perform a check at step856 to determine whether a time-out flag has been generated by thecontrol system 99 indicating a time-out error. If a time-out flag hasnot been generated, the check is made again to determine if the suturerestraint device has been fully extended (step 855). If the time-outflag is generated by the control system as a time-out error, the processwill be terminated and prompted for reinitialization at step 959 in FIG.4(i).

(6) At the above-mentioned optional workstation 625 of FIG. 1, thepackage tray 420 and its contents are exposed to external visualinspection to facilitate a viewer or video camera to ascertain whetherany of the sutures are missing, as a result of the suture windingprocess, or, whether any sutures extend outwardly of the channel ortray, and whether the needles are properly parked in the tray andattached to their associated sutures.

(7) At a cover-applying and attaching workstation 650, as shown in FIG.1, to which the tray 420 is to be indexed from the precedingworkstation, there is located a cover-applying apparatus 620incorporating a pressing die structure 622 for attaching a cover to thetray 420, as illustrated in FIGS. 40 through 44 of the drawings, and forproducing the suture FIG. 50(c), supply line 701a supplies pressurizedair package as shown in FIG. 47.

The apparatus 620 which is essentially mounted on a suitable fixedsupport proximate the perimeter of the rotary turret, includes anupstanding framework 624 which includes a pivot arm structure 626hingedly mounted therein and being articulatable about a horizontalpivot axis 628 for movement between a vertical position facing thebottom end 630 of a cover supply hopper or chute 632 and a horizontalposition facing a tray mounted on platform 542 which has been indexed tothis workstation. A cover pressing die 622 is mounted at the outer orfree end of the pivot arm structure 626, with a plurality of resistantvacuum cups for engaging and holding the cover as it is withdrawn fromhopper 632.

The pivot arm structure 626 with a pressing die 622 thereon, whenupright, is adapted to engage and withdraw a tray cover which isdimensioned in conformance with the configuration of the tray. The pivotarm 626 with the pressing die 622 at its outer free end and the coverpositioned thereon is swung into horizontal axial alignment with thetray on the support platform 542, as shown in FIG. 40, and throughsuitable actuating means, such as by means of a pneumatic cylinder, thepressing die 622 is extended towards and into contact with the tray onplatform 542 so as to position the cover on the tray. The pressing die622 contains suitable surface structure, as shown in FIG. 39, forfastening the cover to the tray, as set forth hereinbelow.

The tray cover 651 is basically a flat cover which may be of a suitablyimprinted paperboard or the like material, and is applied to be fastenedto the tray 420 by means of pressure die 622, as shown in FIG. 45, withthe outer dimensions of the cover as previously mentioned beingsubstantially coextensive with the peripheral dimensions of the tray,and with the cover also having apertures 652 in registration with theupstanding guide pins 544 on the platform 542.

Hereby, the surface of the pressure die 622 facing the cover includes afirst surface portion 638 substantially in conformance with the flatsurface of the cover 651 which has been superimposed on the tray 420,and includes three projecting posts 634, preferably at three sides aboutthe surface 638, and as shown in enlarged scale in FIG. 46 of thedrawings, which will engage tabs 656 which overlie recessed portions 654of the tray, and cause the pre-cut tabs 656 to be separated along threeedges thereof, and thereby forming latching tabs 656 which are pressedin V-shapes downwardly into the respective recesses 654 so as to havethe separated edge of the folded tab 656 at that particular locationengage beneath a horizontal wall structure 658 of the tray 420 extendingpartially over the recess 654, thereby latching the cover 651 intocooperative engagement with the upper surface of the tray at threelocations.

The control process 860 for the cover load station 650 is illustrated inFIG. 4(j). The first step indicated as step 861 in FIG. 4(j), is toverify the status of the PACKAGE REJECT bit. This bit may or may nothave been set at step 777 of the prior needle detect process 770 (FIG.4(e)) at the needle detect station. If the bit was set, the cover willnot be applied to the needle-suture package and the process will end. Ifall needles were detected, then the PACKAGE REJECT bit was not set, andthe package cover 651 will be applied.

At step 862 in FIG. 4(j), the air and vacuum supply for the commerciallyavailable vacuum gripper that grips each package cover 651 from thecover stack and loads it onto the plate 540, is turned on. Additionally,a check is made to determine that the pressing die 622 structure ofpivot arm 626 is operational and extended toward the stack of covers.The air and vacuum supply is supplied to the pressing die 622 havingvacuum cups for retrieving a package tray from the stack, and placing apackage tray cover 651 onto the package tray 420. As shown in thepneumatic schematic diagram of FIGS. 50(c) and 50(d), supply line 701asupplies filtered air to vacuum pump 705b which provides the vacuum forthe vacuum gripper 821 to grasp each package cover 651 by vacuumsuction. The operation of the vacuum gripper 821 is controlled by switch707r under the timing and control of the control system 99.

Additionally, air supply line 701a provides the air supply for thegripper arm 626 utilized to manipulate, i.e., extend and retract, thevacuum gripper 821. The operation of the pivot arm 626 is controlled bycontrol lines 704c,d which operate the switch 707s under the timing andcontrol of the control system 99. If it is determined that the airsupply is off or not at the correct operational level as monitored bymonitoring device 703e, then the cycle jam procedure will be implementedat step 775 shown in FIG. 4(j) and explained in further detail below. Averification is made at step 863 of FIG. 4(j) to determine if the vacuumhas been turned on. The system will perform a check at step 864 todetermine whether a time-out flag has been generated by the controlsystem indicating a time-out error. If a time-out flag has not beengenerated, then the vacuum is on (step 862). If the time-out flag isgenerated by the control system as a time-out error, then the cycle jamprocedure will be implemented at step 775 shown in FIG. 4(j).

At step 865 in FIG. 4(j), the control system 99 performs a check on thestack of empty package covers (not shown) to ensure that the stack levelis not too low. If it is determined that the stack of package covers istoo low, then the control system will check if the package cover counteris equal to zero (0) at step 866 in FIG. 4(j). If the counter for thestack of covers is not equal to zero (0) the counter is decremented atstep 867 and the extend stack release signal is given at step 868 toenable a release lever of cover supply chute 632 to extend which enablesthe pressing die 622 to access and vacuum grip the next package traycover 651 from the stack as shown at step 869.

While the stack release lever is being extended, the system will performa check at step 870 to determine whether a time-out flag has beengenerated by the control system indicating a time-out error. If atime-out flag has not been generated, then the release lever has notfully extended (step 869). If the time-out flag is generated by thecontrol system as a time-out error, then the cycle jam procedure will beimplemented at step 775 shown in FIG. 4(j).

As shown in FIG. 4(j) once the cover load gripper (pressing die) 622 hasreached its extended position and has grasped a package tray cover 651,(step 868), the control system initiates a retract stack release signalat step 871 so that the next accessible package tray cover is retainedin the cover supply chute 632 by the stack release lever as the gripperis retracted and rotated to a horizontal position for cover application.

While the stack release lever is retracting (step 871), the system willperform a check at step 872 to determine whether a time-out flag hasbeen generated by the control system indicating a time-out error. If atime-out flag has not been generated at step 872, then the release leverhas fully retracted (step 873). If the time-out flag is generated by thecontrol system as a time-out error, then the cycle jam procedure will beimplemented at step 775 shown in FIG. 4(j).

After the pivot arm 626 carrying a package cover is retracted, it mustbe rotated to an oriented position before being placed upon the packagetray 420. As shown at step 878 in FIG. 4(j), the pivot arm structurehaving pressing die 621 gripping package cover 651 is rotated to ahorizontally oriented position to aid in the positioning of the packagecover onto the package. As shown in FIG. 50(d), pneumatically operatedrotary actuator 880 rotates actuator 880 enables pivot arm 626 to rotatethe package cover to a fully horizontal position. While the rotaryactuator enables pivot arm to rotate the package tray cover 651, to afully horizontal position, the system will perform a check at step 878bto determine whether a time-out flag has been generated by the controlsystem indicating a time-out error. If a time-out flag has not beengenerated, then the cover applying pivot arm has fully rotated (step878a). If the time-out flag is generated by the control system as atime-out error, then the cycle jam procedure will be implemented at step775 shown in FIG. 4(j).

As shown in the pneumatic schematic diagram of FIGS. 50(c) and 50(d),supply line 701a supplies filtered, monitored, and pressurized air tothe rotary actuator 880 which rotates the package cover 651. Theclockwise and counterclockwise operation of the rotary actuator 880, iscontrolled by control lines 704c,d which operate the switch 707t underthe timing and control of the control system 99.

The next step of the cover applying process 860, is to transfer thepackage cover 651 from the vacuum gripper 821 onto the guide pins 544 ofthe package tray 420. To accomplish this, the pressing die 622 of pivotarm 626 is slightly extended and the vacuum mode is off switched at step882 to accomplish the transfer. While the pivot arm is extending thesystem will perform a check at step 884 to determine whether a time-outflag has been generated by the control system indicating a time-outerror. If a time-out flag has not been generated, a check is made againto determine if the vacuum mode has been switched (step 883). If thetime-out flag is generated by the control system as a time-out error,then the cycle jam procedure will be implemented at step 775 shown inFIG. 4(j). The extension of the pneumatic cover gripper arm will drivedies 634 through tab opening 653 to position the tabs 656 into the trayrecesses 654 as illustrated in FIG. 48.

After the transfer of the package cover 651 onto the package tray 420has been completed, the cover pressing die 622 of pivot arm structure626 is retracted from its position at the package dial 500 as shown atstep 885 in FIG. 4(j). While the cover pivot arm 626 is retracting fromits position at the tool nest 516 after transferring a cover, the systemperforms a check at step 887 to determine whether a time-out flag hasbeen generated by the control system indicating a time-out error. If atime-out flag has not been generated, a check is made again to determineif the arm has been fully retracted (step 886). If the time-out flag isgenerated by the control system as a time-out error, then the cycle jamprocedure will be implemented at step 775 shown in FIG. 4(j).

The next to last step of the cover applying process 860, is to rotatethe pivot arm 626 to its initial vertical positioning for enabling thevacuum gripper 821 to pick up another package cover from the stack ofpackage covers. To accomplish this vertical rotation, the rotaryactuator 880 is enabled to rotate as indicated at step 889 in FIG. 4(j).While the rotary actuator enables pivot arm 626 to rotate to its initialvertical position, the system will perform a check at step 891 todetermine whether a time-out flag has been generated by the controlsystem indicating a time-out error. If a time-out flag has not beengenerated, a check is made again to determine if the cover pivot arm 626has fully rotated (step 890). If the time-out flag is generated by thecontrol system as a time-out error, then the cycle jam procedure will beimplemented at step 775 shown in FIG. 4(j).

The final step of the cover load process 860 is to update the counterthat keeps track of the number of package tray covers in the coversupply chute 632 for later comparison (step 865). This is indicated asstep 892 in FIG. 4(j).

(8) Responsive to indexed forward rotation of the package dial 500 to asuccessive workstation, the suture package consisting of the needle andsuture-containing tray 420 and attached cover 651, as shown in FIG. 47,is positioned in alignment on the platform 542 with a package removalunit 670, as illustrated in FIGS. 43 to 45. In FIG. 43 of the drawings,a pivoting arm structure 673 is illustrated in both its horizontal andvertical operative positions, being pivotable along the direction ofdouble-headed arrow D. Suitable grippers 926 are mounted on the pivotingarm structure 673 which is journaled on a stationary frame 674 thelatter of which is somewhat similar in structure to the framework 624 ofthe cover-applying apparatus 620. These grippers 926 are pivotable intoa horizontal orientation and extend outward from arm 673 as a result ofpneumatically operated ram 682, as shown in FIG. 41, for grippingengagement with the suture package. The ram 682 and grippers 926 arethen operated to retract and withdraw the suture package from itssupport surface or platform 542 and the pins mounted thereon. Thegrippers 926 with the therewith clamped suture package is then adaptedto be pivoted upward into a vertical orientation in alignment with theopening 676 in the bottom 678 of a hopper or chute 680 for receiving astack of completed suture packages through the upward pushing action ofa pneumatic cylinder 682 biasing the suture packages into the chute 680,as shown in FIGS. 43 and 45. The bottom 678 of the chute includes aretaining lip 684 to prevent the suture packages from falling downwardlyout of the chute. Subsequently, the grippers 926 are pneumaticallyretracted within the arm structure 673 which is pivoted to itshorizontal position to receive the next completed suture package.Alternatively, this particular, basically optional structure forremoving the completed suture package from the support surface may beeliminated, if desired, and replaced by a manual suture package-removingoperation.

From the chute 680, the suture packages may then be removed eitherthrough the intermediary of a further mechanism (not shown) or manuallytransported for additional processing; for example, such as sterilizing,and/or additional overwrapping, or the like.

The control process 900 for unloading suture packages at station 700 isillustrated in FIG. 4(k). The first step indicated as step 903 in FIG.4(k) is the command to extend the package grippers 926 toward thepackage for gripping thereof. A continuous check is made at step 905 inFIG. 4(k) to determine whether the suture package grippers 926 have beenextended. While the unload package gripper arm is extending to grasp thepackage for unloading, the system will perform a check at step 907 todetermine whether a time-out flag has been generated by the controlsystem 99 indicating a time-out error. If a time-out flag has not beengenerated, the check is made again to determine if the unload packagegripper arm 673 has been fully extended (step 905). If the time-out flagis generated by the control system indicating a time-out error, then thecycle jam procedure will be implemented at step 775 shown in FIG. 4(k).

As shown in the pneumatic schematic diagram of FIGS. 50(c) and 50(d),supply line 701a supplies the pressurized air to pneumatically operate,i.e., extend and retract, the unload package gripper arm 673. Theoperation of the unload package gripper arm 673 is controlled by controllines 704c,d which operate the switch 707u under the timing and controlof the control system 99.

As shown in FIG. 4(k), once the unload package gripper arm 673 hasreached its extended position, the control system initiates a closegripper command at step 909 for enabling the gripper fingers 926 of theunload package gripper 673 to engage the package. While the pneumaticunload package gripper fingers 926 are closing, the system will performa check at step 911 to determine whether a time-out flag has beengenerated by the control system indicating a time-out error. If atime-out flag has not been generated, a check is made again to determineif the unload package gripper fingers 926 have been closed (step 910).If the time-out flag is generated by the control system as a time-outerror, then the cycle jam procedure will be implemented at step 775shown in FIG. 4(k).

As shown in the pneumatic schematic diagram of FIGS. 50(c) and 50(d),supply line 701a supplies filtered air pneumatically operate unloadpackage gripper fingers 926 for grasping each completed package fordischarge from the suture wind and packaging dial. The operation of thegripper fingers 926 is controlled by switch 707v under the timing andcontrol of the control system 99.

After the pneumatic unload package gripper fingers 926 have grasped thepackage, the unload package gripper arm 673 is retracted to a positionaway from the platform 542 as indicated at step 912 in FIG. 4(k). Whilethe pneumatic unload package gripper arm 673 is retracting, the systemwill perform a check at step 914 to determine whether a time-out flaghas been generated by the control system indicating a time-out error. Ifa time-out flag has not been generated, a check is made again todetermine if the unload package gripper arm 673 has reached itsretracted position (step 913). If the time-out flag is generated by thecontrol system as a time-out error, then the cycle jam procedure will beimplemented at step 775 shown in FIG. 4(k).

The next step of the unload package process 900 is to check whether thepackage cover 651 is present by checking for the package label by asuitable sensor means (not shown) as indicated at step 915 in FIG. 4(l).If it is determined at step 915 of FIG. 4(l) that the cover of thecurrently indexed package is not present, the control system willcommand the unload package gripper fingers 926 to release its grip onthe package as indicated at step 918 in FIG. 4(l), and, in essence,reject the package. While the pneumatic unload package gripper fingers926 are opening at step 919, the system will perform a check at step 920to determine whether a time-out flag has been generated by the controlsystem indicating a time-out error. If a time-out flag has not beengenerated, the package has been rejected (scrapped) as shown at step921. If the time-out flag is generated by the control system as atime-out error, then the cycle jam procedure will be implemented at step775 shown in FIG. 4(l).

If the cover is present as determined at step 915, then the packageunload process 900 continues. The next step, indicated as step 922 inFIG. 4(l), is to remove the safe to unload light, and, at step 923,determine whether the package unload area is clear. If the packageunload area is not clear, then the cycle jam procedure will beimplemented at step 775 shown in FIG. 4(l). If the package unload areais clear, then the next step, indicated as step 931 in FIG. 4(l), is torotate the unload package gripper arm to a vertical position to aid inunloading the package within chute 680. To accomplish this verticalrotation, rotary actuator 928 is enabled to rotate the package asindicated at step 931 in FIG. 4(l). While the rotary actuator 928enables pneumatic unload package gripper arm 673 to rotate to a verticalposition, the system will perform a check at step 932 to determinewhether a time-out flag has been generated by the control systemindicating a time-out error. If a time-out flag has not been generated,then the unload package gripper arm has fully rotated (step 933). If thetime-out flag is generated by the control system as a time-out error,then the cycle jam procedure will be implemented at step 775 shown inFIG. 4(l). As shown in the pneumatic schematic diagram of FIGS. 50(c)and 50(d), supply line 701a supplies filtered, monitored, andpressurized air to the rotary actuator 928 which rotates the unloadpackage gripper arm 673. The clockwise and counterclockwise operation ofthe rotary actuator 928, is controlled by control lines 704c,d whichoperate the switch 707w under the timing and control of the controlsystem 99.

The next step of the package unload process 900, is to transfer thepackage from the fingers of the unload package gripper arm 673 into thevertically positioned chute 680. To accomplish the transfer, the covergripper ram 682 of arm 673 is extended vertically to position thepackage within the chute as indicated at step 934 of FIG. 4(l). Whilethe pneumatically operated gripper ram is extending as shown at step935, the system will perform a check at step 936 to determine whether atime-out flag has been generated by the control system indicating atime-out error. If a time-out flag has not been generated, then the ramhas fully extended as shown in step 935. If the time-out flag isgenerated by the control system as a time-out error, then the cycle jamprocedure will be implemented at step 775 shown in FIG. 4(l).

As shown in FIG. 4(m), once the unload package gripper ram 628 has beenextended to initiate the transfer of the package to the vertical chute680, the control system initiates an open gripper finger command at step938 for disengaging the gripper fingers 926 from the unloaded package.While the pneumatic unload package gripper fingers 926 are opening atstep 939, the system will perform a check at step 941 to determinewhether a time-out flag has been generated by the control systemindicating a time-out error. If a time-out flag has not been generated,the process continues. If the time-out flag is generated by the controlsystem as a time-out error, then the cycle jam procedure will beimplemented at step 775 shown in FIG. 4(m).

After the pneumatic unload package gripper fingers 926 have disengagedthe package, the unload package gripper ram 682 is retracted to aposition away from the vertical chute 680 as indicated at step 942 inFIG. 4(m). While the pneumatic unload package gripper ram 682 isretracting at step 943, the system will perform a check at step 944 todetermine whether a time-out flag has been generated by the controlsystem indicating a time-out error. If a time-out flag has not beengenerated, then the unload package gripper ram has been fully retractedwithin pivot arm structure 673. If the time-out flag is generated by thecontrol system as a time-out error, then the cycle jam procedure will beimplemented at step 775 shown in FIG. 4(m).

At step 945 in FIG. 4(m), the safe to unload lamp (not shown) is turnedon, indicating that it is safe to unload a package and that the unloadarea is clear.

At step 952 in FIG. 4(m), the control system 99 performs a check on thestack of completed packages (not shown) to ensure that the stack levelis not too high. If it is determined that the number of completedpackages in the stack is too high at step 954, then the control systemwill generate a warning signal at step 956 indicating that the stacklevel is too high and inform an operator to remove the stack. Thiswarning will remain on for a duration of time corresponding to theunloading of fifteen (15) completed packages, (i.e., fifteen (15)rotations of the suture wind and package dial 500). The control systemwill decrement a counter (not shown) from fifteen (15) for eachadditional package inserted after the warning light is activated at step957 in FIG. 4(m). If the counter for the insertion of completed packagesin the stack reaches zero (0) before corrective action is taken, thenthe control system will generate an alarm signal at step 960 of FIG.4(m) and the process will be terminated and the cycle jam procedure willbe implemented at step 775 shown in FIG. 4(m). If corrective action istaken (by removing the stack of completed packages), then the command toinitiate the rotation of the unload package gripper arm 673 to ahorizontal position for receiving the next completed package, isgenerated at step 962. While the rotary actuator 928 enables pneumaticunload package gripper arm 673 to rotate to a horizontal position atstep 963, the system will perform a check at step 965 to determinewhether a time-out flag has been generated by the control systemindicating a time-out error. If a time-out flag has not been generated,then the unload package gripper arm has fully rotated (step 963) and thepackage unload process 900 is completed. If the time-out flag isgenerated by the control system as a time-out error, then the cycle jamprocedure will be implemented at step 775 shown in FIG. 4(m).

FIG. 4(n) illustrates the cycle jam procedure 775 indicating a time-outerror whereby the dedicated procedure being performed could not becompleted within the allotted time allowed for that particularprocedure. When the cycle jam is initiated the first step 781 is to stopthe current machine cycle. At step 782, a display is generated on asuitable display mechanism (not shown) instructing an operator to takeappropriate remedial action, if possible. Thus, at step 783, an operatormay manually investigate and correct the particular problem or error.When the operator is through correcting the problem, the control systemwill initiate a command to reset the system as shown at step 784 in FIG.4(n). At step 785, the control system will make a determination ofwhether the particular error has cleared, or, whether the particularproblem has been solved. If not, the display error message is againinitiated at step 782. If the problem was solved, a determination ismade at step 786 as to whether the doors of the machine housing (notshown) have been shut. If not, an appropriate display error message isagain initiated at step 782. If the doors of the machine housing havebeen shut and the error solved, then the operator will be prompted toenable the start button to start the process again as shown at step 787in FIG. 4(n).

As mentioned above at the needle-suture load to package station 600, therotary dial 500 is indexed eight (8) times to hand-off eight armedneedles to an empty package tray. The control system will verify thateight needles have been handed off at step 967 in FIG. 4(a). At step967a, the set DONE bit that had been set at step 967 in FIG. 4(a) iscleared, thus indicating that a new package is ready to be indexed tothe station needle-suture load to package station 600. Finally, at step968 of FIG. 4(a), the suture wind and packaging dial 500 is rotated toindex the next empty package to the needle-suture load to packagestation 600. A check is made at step 968a to verify when the packagingdial 500 has stopped indexing. The system will perform a check at step968b to determine whether a time-out flag has been generated by thecontrol system 99 indicating a time-out error. If a time-out flag hasnot been generated, the check is made again to determine if the largepackaging dial has finished rotating (indexing) the rotary disk member510 for approximately 45 degrees to the next successive workstation. Ifthe time-out flag is generated by the control system 99 as a time-outerror, the process will be terminated and prompted for reinitializationat step 959 in FIG. 4(a).

The reinitialization routine, shown in FIGS. 49(a) to 49(e) describe thesteps necessary to ensure proper running of the automatic needle swagingand automatic packaging machines when reinitialization is called forduring run-time. Additionally, an operator may perform this routine atstart-up to initialize all system components.

As shown at step 970 of FIG. 49(a), the operator is prompted to threadthe suture, i.e., wind the suture through the tensioner and around theplurality of pulleys located at the swaging tower as indicated at step970a. Next, at step 972 all error flags that might have been set, arecleared. If all the errors are cleared, a start initialization messageis displayed at step 973a of FIG. 49(a) that prompts the operator toenter the appropriate key (step 973b) to begin system initialization.Else, the operator is prompted to thread the suture again at step 972a,i.e., wind the suture through the tensioner and around the plurality ofpulleys located at the swaging tower as indicated at steps 970 and 970a.

At step 974 in FIG. 49(b), the both left and right grippers are returnedto their home positions. At steps 974a,b, a verification is made toensure that each gripper is returned within the allotted time asprogrammed. If not, an appropriate message is displayed at step 971 ofFIG. 49(a). The next step is to move the right or lead gripper to itssuture insertion position along the suture tower as indicated at step976 in FIG. 49(b). At steps 976a,b, a verification is made to ensurethat the gripper is positioned within the allotted time as programmed.If not, an appropriate message is displayed at step 971 of FIG. 49(a).The gripper is then moved to its clamping position at step 977 in FIG.49(a) and a verification is made at step 977a,b to ensure that thegripper is correctly positioned within the allotted time as programmed.If not, an appropriate message is displayed at step 971 of FIG. 49(a).At step 979 in FIG. 49(c), the lead gripper is closed so as to engagethe threaded suture strand. Next, the cutter assembly is reciprocatedfrom a retracted position to the cutting position as shown as step 980and back to the retracted position as shown as step 981 in FIG. 49(c).The extended movement of the cutter assembly is verified at steps 980a,bto ensure that it is accomplished within the allotted time asprogrammed. Likewise, the retracted movement is verified at steps 981a,bto ensure that it is accomplished within the allotted time asprogrammed.

At steps 982, 982a, and 982b in FIG. 49(c), the check is again made toplace the right or lead gripper at its home position along the tower.The right gripper is then positioned at the clamping position along theservo tower at step 983 in FIG. 49(d). The positioning of the secondgripper is verified at steps 983a,b to ensure that it is accomplishedwithin the allotted time as programmed.

Next, as indicated at step 984 of FIG. 49(d), a determination is madeconcerning the status of the swage dies and swage cylinders. At step985, the swage cylinder, specifically the movable swage die 369 isenabled to its normal, unbiased position and a verification is made atsteps 985a,b to ensure that it is initialized within the allotted time.

The initialization routine 959 also includes a check of the status ofthe pull-test transducer located at the pull-test station, as indicatedat steps 986a,b of FIG. 49(d).

Next, as indicated at steps 987a of FIG. 49(e), the swage dialservomotor is activated to its home position, i.e., with the firstmulti-axis gripper facing the needle sorting station 100. A verificationis made at steps 987b,c to ensure that the servomotor is indexed to ahome position within the allotted time as programmed.

At step 988a the solenoid for enabling the engagement jaws of aprecision conveyor boat 108 to retract to their open, non-engagingposition is activated. A verification that the retraction of theengagement jaws is accomplished within the allotted time, is made atsteps 988b,c in FIG. 49(e). At steps 989a,b,c a verification is madeensuring that the servomotor controlling the movement of precisionconveyor 107 is placed in its initial position within the allotted timeas programmed.

At step 990a in FIG. 49(e), the elevator assembly at the needle-load topackage station 600 comprising servomotor 430 and elevator shaft 445 isactivated to return to its home position. A verification is made atsteps 990b,c to confirm that the elevator assembly is returned to itshome position within the allotted time as programmed.

At steps 991 and 993 of FIG. 49(f), a verification is made to ensurethat the respective pneumatically operated cylinders for controllingrespectively, package load arm 758 and suture wind stylus slide 578, arein their initial home positions. A similar determination is made at step992 to ensure that the operation of the needle detect unit 560 is at itshome or retracted position.

Next, at steps 994a,b,c of FIG. 49(f), a verification that thepneumatically operated suture restraint plate 612 is retracted to itshome position within the allotted time as programmed, is performed.Similarly, at step 996a the servomotor for controlling the rotation ofthe support platform and package tray and hence, the winding of thesuture bundle, is activated to its home position and a verification ismade at steps 996b,c of FIG. 49(g) that it is done in the allotted timeas programmed.

At steps 998 and 999 of FIG. 49(g), a verification is made to ensurethat the respective pneumatically operated cylinders for controllingrespective cover load gripper arm 626, and unload package gripper arm924, are retracted to their respective initial positions. At step 1001,a verification that the tilted cam 533 for tilting the support platformholding the package tray 420 at the needle-load to package station 600is in its home position, is made.

Next, at step 1002a of FIG. 49(g), the suture wind and package dialservomotor is activated to its home position. A verification is made atsteps 1002b,c to ensure that the servomotor is indexed to a homeposition within the allotted time as programmed.

Finally, if all the above initialization routines are verified, anelectronic signal indicating that the system is ready to run, is set atstep 1005 of FIG. 49(g). A message to the operator informing him toremove suture restraint plate is generated at step 1006 of FIG. 49(g).It should be noted that if time-out errors occur for any of the aboveinitialization routines, the message prompting the operator to threadthe suture (step 970) is again displayed and the corrective action mustbe taken.

While the invention has been particularly shown and described withrespect to the preferred embodiments thereof, it will be understood bythose skilled in the art that the foregoing and other changes in formand details may be made therein without departing from the spirit andscope of the invention, which should be limited only by the scope of theappended claims.

What is claimed:
 1. A method of automatically swaging surgical needlesto associated sutures, said method comprising:(a) sequentially feeding aplurality of needles and a plurality of associated sutures between apair of swaging dies, with a first of said pair being adjustably fixed;(b) sequentially swaging each of said needles to an associated suture bydriving the second of said pair of dies towards the adjustably fixed dieto form a plurality of needle-suture assemblies; (c) pull testing eachnth needle-suture assembly to obtain an nth sample failure value; (d)comparing said nth sample failure value with a low failure thresholdvalue and generating a first signal if said nth sample failure value isbelow said low failure threshold value; and (e) incrementally adjustingthe position of said adjustably fixed die in response to said firstsignal to move said adjustably fixed die an incremental distance towardsthe second die.
 2. A method of automatically swaging surgical needles toassociated sutures as claimed in claim 1 wherein said method alsoincludes the steps of:(a) comparing said nth sample failure value with ahigh failure threshold value and generating a second signal if said nthsample failure value is above said high threshold value; (b)incrementally adjusting the position of said adjustably fixed die inresponse to said second signal to move said adjustably fixed die anincremental distance away from the second die.
 3. The method ofautomatically swaging surgical needles to associated sutures as claimedin claim 2 wherein said first of said pair of swaging dies includes awedge follower located at one end thereof and a wedge assemblypositioned to move transverse to said wedge follower, wherein the stepof incrementally adjusting the position of said adjustably fixed diefurther includes the steps of:(a) inputting either of said first andsecond signals to a servomotor means for precisely rotating a swageadjust screw of a predetermined pitch in accordance with either of saidfirst and second signals; (b) translating said rotation of said swageadjust screw into linear motion of said wedge assembly, said wedgeassembly moving transverse to said wedge follower of said first swagingdie; and (c) moving said wedge follower of said first of said pair ofswaging dies in incremental units correlating with said transverselinear motion of said wedge assembly.
 4. The method of automaticallyswaging surgical needles to associated sutures as claimed in claim 1further including the steps of:(a) sequentially drawing a plurality ofindefinite length suture strands to said pair of swaging dies; (b)sequentially inserting free ends of said indefinite length suturestrands into respective suture receiving openings formed in saidplurality of needles prior to swaging thereof; and, (c) sequentiallycutting said indefinite length suture strands to definite length afterswaging said free ends to said needles, said strands being cut apredetermined distance from said free ends to form a plurality ofneedle-suture assemblies each having a said associated suture ofdefinite length depending from said needle.
 5. The method ofautomatically swaging surgical needles to associated sutures as claimedin claim 4 further including the steps of:(a) mounting an empty packagetray on a support structure; (b) successively inserting saidneedle-suture assemblies onto predetermined needle-clamping locations insaid tray to form an array of needles and attached sutures dependingtherefrom; (c) gathering said depending suture portions into a bundle ofstrands and imparting axial tension thereto; (d) rotating said packagetray about an axis extending normal to the plane of said tray with adrive means; and (e) winding said bundle of strands into a peripheralchannel formed in said package tray.
 6. The method of automaticallyswaging surgical needles to associated sutures as claimed in claim 5wherein the step of successively inserting said needle-suture assembliesinto said package tray further includes the step of incrementallyvertically displacing a package tray support structure with said packagetray attached thereto so as to correlate the successive insertion ofsaid needle-suture assemblies with said predetermined needle-clampinglocations in said tray to form said needle array.
 7. The method ofautomatically swaging surgical needles to associated sutures as claimedin claim 6 wherein the step of incrementally vertically displacing saidsupport structure and said package tray further includes the step ofgrippingly engaging and conveying a specified quantity of needle-sutureassemblies in successive sequence into said tray in synchronism with theincremental vertical displacement of said support structure and saidpackage tray.
 8. The method of automatically swaging surgical needles toassociated sutures as claimed in claim 7 further including the step ofapplying a cover to said package tray to form a completed suture packagecontaining said needles and attached wound sutures.
 9. The method ofautomatically swaging surgical needles to associated sutures as claimedin claim 8 further including the step of disengaging said completedsuture package from said support structure.
 10. The method ofautomatically swaging surgical needles to associated sutures as claimedin claim 8 further including applying a cover to said package tray toform a completed suture package containing said needles and attachedsutures, said cover being applied by a cover applying means, said coverapplying means including a pivotable arm having grippers for grippingsaid covers, said method further including the steps of:(a) successivelyobtaining individual covers from a supply of covers; (b) pivoting saidgrippers into alignment with said tray on said support structure; (c)extending said grippers to position a cover gripped thereby on saidtray; (d) releasing said cover; and, (e) withdrawing said grippers. 11.The method of automatically swaging surgical needles to associatedsutures as claimed in claim 5 wherein the step of gathering saiddepending suture portions includes the step of imparting asubatmospheric pressure to said depending suture portions to cause saiddepending suture portions to be tensioned into said bundle of strands.12. The method of automatically swaging surgical needles to associatedsutures as claimed in claim 5 wherein the step of winding said bundle ofstrands includes the steps of:(a) contacting said tensioned sutureportions with an arm structure means; and (b) pivoting said armstructure means to bias said suture portions into an orientationfacilitating winding of said suture portions into the tray channel. 13.The method of automatically swaging surgical needles to associatedsutures as claimed in claim 12 wherein said winding step furtherincludes the steps of:(a) operatively contacting a stylus means withsaid tensioned and bundled suture strands; (b) guiding said bundle ofstrands into said tray channel with said stylus means to facilitatewinding of said sutures into said tray during rotation of said tray. 14.The method of automatically swaging surgical needles to associatedsutures as claimed in claim 13 wherein said stylus means includes styluslegs for contacting said bundle of strands, a piston rod for mountingsaid stylus legs at one end thereof for axial movement, and, astationary piston cylinder within which said piston rod is mounted, saidmethod further including the step of exerting pressurized air againstsaid piston rod within said stationary piston cylinder to providereciprocatory motion thereof to enable said stylus legs to engage intoand follow said peripheral tray channel during rotation of said tray.15. The method of automatically swaging surgical needles to associatedsutures as claimed in claim 14 wherein said package tray is supported ona support structure including a cam plate, and said stylus means furtherincludes cam follower means mounted on said piston rod proximate saidstylus legs, said method further comprising contacting a peripheralcamming surface on said cam plate by said cam follower means in responseto said pressure being exerted against said piston rod by pressurizedair in said piston cylinder.
 16. The method of automatically swagingsurgical needles to associated sutures as claimed in claim 15 whereinsaid tray includes a plurality of resilient cantilevered fingersextending over said peripheral channel for protectively maintaining thesutures in said channel, said stylus legs engaging beneath successive ofsaid fingers for raising said fingers during rotation of said tray toguide said bundle of strands therebeneath and bias said bundle ofstrands into and towards the bottom of said tray channel.
 17. The methodof automatically swaging surgical needles to associated sutures asclaimed in claim 16 further including the step of inhibitingdisplacement of said package tray on said support structure bycontacting said tray with a restraint means during rotation of saidtray, wherein said restraint means is operatively connected to saiddrive means.
 18. The method of automatically swaging surgical needles toassociated sutures as claimed in claim 1 wherein step (c) of pulltesting each nth needle-suture assembly further includes the stepsof:(a) supporting the needle of said nth needle-suture assembly; (b)gripping said associated suture of said nth needle with a grippingmeans, said gripping means including a means for applying a force ofpredetermined value to said suture; (c) applying said force ofpredetermined value to said suture while said suture is gripped by saidgripping means; and, (d) measuring said force applied to obtain said nthsample failure value.